Supplementary appendixThis appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors.

Supplement to: Patel AN, Henry TD, Quyyumi AA, et al, for the ixCELL-DCM Investigators. Ixmyelocel-T for patients with ischaemic heart failure: a prospective randomised double-blind trial. Lancet 2016; published online April 4. http://dx.doi.org/10.1016/S0140-6736(16)30137-4.

Supplement Table 1. Primary endpoint: All-cause Death, Cardiovascular Hospitalizations or Unplanned Outpatient/ED Visits for Treatment of

Acute Decompensated Heart Failure modified ITT n=114. There were statistically significantly fewer events in the Ixmyelocel-T group compared

to the placebo group *(p = 0·0107, Poisson regression) Rate Ratio [95% CI]: 0·59 [0·40-0·89]· Sensitivity endpoint including the IP procedure

related events was positive *(p = 0·0082, Poisson regression) Rate Ratio [95% CI]: 0·58 [0·39-0·87].

_____Primary Endpoint_____

Without IP Procedure Related

Events

_____Sensitivity Endpoint_____

With IP Procedure Related Events

Control

(N=55)

Ixmyelocel-T

(N=59)

Control

(N=55)

Ixmyelocel-T

(N=59)

P-Valuea 0.0107 0.0082

Rate Ratio [95% CI] 0.59 [0.40, 0.89] 0.58 [0.39, 0.87]

Events/100 patient years 121.73 72.16 123.79 72.16

Patient years Exposed 48.5 55.4 48.5 55.4

Total Events 59 40 60 40

Distribution of Events by Patient, n

(%)

0 27 (49.1) 36 (61.0) 26 (47.3) 36 (61.0)

>=1 28 (50.9) 23 (39.0) 29 (52.7) 23 (39.0)

1 11 (20.0) 13 (22.0) 12 (21.8) 13 (22.0)

2 11 (20.0) 4 ( 6.8) 11 (20.0) 4 ( 6.8)

3 2 ( 3.6) 5 ( 8.5) 2 ( 3.6) 5 ( 8.5)

4 2 ( 3.6) 1 ( 1.7) 2 ( 3.6) 1 ( 1.7)

5 1 ( 1.8) 0 ( 0.0) 1 ( 1.8) 0 ( 0.0)

7 1 ( 1.8) 0 ( 0.0) 1 ( 1.8) 0 ( 0.0)

Supplement Figure 1. Kaplan-Meier Analysis: The secondary endpoint of time to first cardiovascular event of ixmyelocel-T versus

placebo modified ITT n=114 (p=0·1434, Cox Regression HR 0·66· (0·38-1·15) 95% CI.

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

202006 A612 Intraventricular

haemorrhage /

INTRAVENTRICULAR

HEMORRHAGE

2014-12-

18/ 79

0

A613 Respiratory failure /

RESPIRATORY

FAILURE

2014-12-

18/ 79

0

A454 Intracranial aneurysm /

RUPTURED DUAL

ANTERIOR

COMMUNICATING

ARTERY ANEURYSMS

2014-12-

18/ 79

Y 2014-12-20 Y 2014-12-18 2

A462 Subarachnoid haemorrhage

/ SUBARCHNOID

HEMORRHAGE

2014-12-

18/ 79

0

203002* A469 Thrombosis / BLOOD

CLOT

2015-01-

01/ 296

Y 2015-01-01 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 5 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

202006 A612 Intraventricular

haemorrhage /

INTRAVENTRICULAR

HEMORRHAGE

2014-12-20 2014-12-20

/ 81

NOT RELATED Y

A613 Respiratory failure /

RESPIRATORY

FAILURE

2014-12-20 2014-12-20

/ 81

NOT RELATED Y

A454 Intracranial aneurysm /

RUPTURED DUAL

ANTERIOR

COMMUNICATING

ARTERY ANEURYSMS

2014-12-20 2014-12-20

/ 81

NOT RELATED Y

A462 Subarachnoid haemorrhage

/ SUBARCHNOID

HEMORRHAGE

2014-12-20 2014-12-20

/ 81

NOT RELATED Y

203002* A469 Thrombosis / BLOOD

CLOT

2015-01-02 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 6 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

204001 A363 Cardiac failure acute /

ACUTE ON CHRONIC

SYSTOLIC HEART

FAILURE

2013-10-

28/ 35

Y Y 2013-10-28 1

A365 Cardiac failure /

DECOMPENSATED

HEART FAILURE

2013-12-

09/ 77

Y Y 2013-12-09 2014-07-25 1

205002 A394 Dehydration /

DEHYDRATION

2014-06-

19/ 93

Y 2014-06-19 1

205007 A524 Cardiac failure congestive /

WORSENING

CONGESTIVE HEART

FAILURE

2015-05-

10/ 243

Y 2015-06-24 Y 2015-06-20 2

207001 A347 Confusional state /

WORSENING

CONFUSION

2013-05-

31/ 45

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 7 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A338 Hypercalcaemia /

WORSENING OF

HYPERCALCEMIA

2013-05-

31/ 45

Y 2013-05-31 0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 8 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

204001 A363 Cardiac failure acute /

ACUTE ON CHRONIC

SYSTOLIC HEART

FAILURE

2013-11-07 2014-07-25 /

305

NOT RELATED

A365 Cardiac failure /

DECOMPENSATED

HEART FAILURE

2013-12-23 2014-07-25 /

305

NOT RELATED

205002 A394 Dehydration /

DEHYDRATION

2014-06-20 NOT RELATED

205007 A524 Cardiac failure congestive /

WORSENING

CONGESTIVE HEART

FAILURE

2015-06-24 2015-06-24

/ 288

NOT RELATED

207001 A347 Confusional state /

WORSENING

CONFUSION

2013-06-06 NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 9 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A338 Hypercalcaemia /

WORSENING OF

HYPERCALCEMIA

2013-06-06 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 10 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

210004 A597 Cardiac failure / ACUTE

ON CHRONIC SYSTOLIC

& DIASTOLIC HF

2014-05-

01/ 21

0

A381 Chest pain / CHEST PAIN 2014-05-

01/ 21

Y Y 2014-05-01 1

A391 Klebsiella bacteraemia /

KLEBSIELLA

BACTEREMIA

2014-05-

02/ 22

0

Cardiac failure / ACUTE

ON CHRONIC HF,

SYSTOLIC &

DIASTOLIC

2014-05-

15/ 35

0

A393 Hypotension /

HYPOTENSION

2014-06-

04/ 55

Y 2014-06-04 1

A398 Pneumonia /

PNEUMONIA

2014-06-

10/ 61

Y 2014-06-10 0

211004 A510 Sepsis / SEPSIS 2015/ Y 2015-05-06 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 11 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A571 Small intestinal obstruction

/ SMALL BOWEL

OBSTRUCTION

2015/ 0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 12 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

210004 A597 Cardiac failure / ACUTE

ON CHRONIC SYSTOLIC

& DIASTOLIC HF

2014-05-13 NOT RELATED Y

A381 Chest pain / CHEST PAIN 2014-05-13 NOT RELATED

A391 Klebsiella bacteraemia /

KLEBSIELLA

BACTEREMIA

2014-05-13 NOT RELATED Y

Cardiac failure / ACUTE

ON CHRONIC HF,

SYSTOLIC &

DIASTOLIC

NOT RELATED Y

A393 Hypotension /

HYPOTENSION

2014-06-05 NOT RELATED

A398 Pneumonia /

PNEUMONIA

2014-06-15 NOT RELATED

211004 A510 Sepsis / SEPSIS 2015-05-06 2015-05-06

/ 323

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 13 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A571 Small intestinal obstruction

/ SMALL BOWEL

OBSTRUCTION

2015-05-06 2015-05-06

/ 323

NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 14 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

211006 A426 Chest pain / CHEST PAIN 2014-10-

24/ 121

Y 2014-10-24 1

A427 Cardiac failure / HEART

FAILURE

EXACERBATION

2014-11-

04/ 132

Y Y 2014-11-04 1

212001# A343 Pyrexia / FEVER,

UNKNOWN ETIOLOGY

2013-06-

16/ 12

Y 2013-06-18 0

A345 Cardiogenic shock /

CARDIOGENIC SHOCK

2013-06-

18/ 14

Y 2013-06-21 1

212004 A466 Multiple fractures /

MULTIPLE FRACTURES

2015-01-

04/ 250

Y 2015-01-04 0

A467 Respiratory distress /

RESPIRATORY

DISTRESS

2015-01-

08/ 254

0

A492 Metabolic encephalopathy /

METABOLIC

ENCEPHALOPATHY

2015-04-

13/ 349

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 15 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

211006 A426 Chest pain / CHEST PAIN 2014-10-29 NOT RELATED Y

A427 Cardiac failure / HEART

FAILURE

EXACERBATION

2014-11-14 NOT RELATED

212001# A343 Pyrexia / FEVER,

UNKNOWN ETIOLOGY

2013-06-21 2013-06-21

/ 17

UNLIKELY

A345 Cardiogenic shock /

CARDIOGENIC SHOCK

2013-06-21 2013-06-21

/ 17

UNLIKELY

212004 A466 Multiple fractures /

MULTIPLE FRACTURES

2015-01-18 NOT RELATED

A467 Respiratory distress /

RESPIRATORY

DISTRESS

2015-01-18 NOT RELATED Y

A492 Metabolic encephalopathy /

METABOLIC

ENCEPHALOPATHY

2015-05-01 NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 16 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

212004 A491 Urinary tract infection /

URINARY TRACT

INFECTION

2015-04-

13/ 349

Y 2015-04-13 0

A493 Atrial fibrillation /

ATRIAL FIBRILLATION

WITH RAPID

VENTRICULAR RATE

2015-04-

15/ 351

0

A495 Renal failure acute /

ACUTE RENAL

FAILURE

2015-04-

16/ 352

0

A496 Coagulopathy /

COAGULOPATHY

2015-04-

16/ 352

0

A494 Septic shock / SEPTIC

SHOCK

2015-04-

16/ 352

0

A497 Ischaemic hepatitis /

SHOCK LIVER

2015-04-

16/ 352

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 17 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

212004 A491 Urinary tract infection /

URINARY TRACT

INFECTION

2015-05-01 NOT RELATED

A493 Atrial fibrillation /

ATRIAL FIBRILLATION

WITH RAPID

VENTRICULAR RATE

2015-05-01 NOT RELATED Y

A495 Renal failure acute /

ACUTE RENAL

FAILURE

2015-05-01 NOT RELATED Y

A496 Coagulopathy /

COAGULOPATHY

2015-05-01 NOT RELATED Y

A494 Septic shock / SEPTIC

SHOCK

2015-05-01 NOT RELATED Y

A497 Ischaemic hepatitis /

SHOCK LIVER

2015-05-01 NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 18 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

212008 A464 Coronary artery disease /

WORSENING

CORONARY ARTERY

DISEASE

2015-01/ Y 2015-01-29 1

A545 Diarrhoea / DIARRHEA 2015-08-

12/ 357

Y 2015-09-01 0

213007 A382 Diabetic ketoacidosis /

DIABETIC

KETOACIDOSIS

2014-05-

07/ 7

Y 2014-05-07 1

215001 A349 Syncope / SYNCOPE 2013-07-

05/ 30

Y 2013-07-05 1

A354 Cardiac death / CARDIAC

DEATH

2013-07-

23/ 48

Y 2013-07-23 1

215002 A350 Ventricular fibrillation /

VENTRICULAR

FIBRILLATION

2013-07-

11/ 2

Y 2013-07-11 0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 19 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

215009 A411 Cardiac failure congestive /

CHF EXACERBATION -

ACUTE ON CHRONIC

2014-09-

05/ 38

Y Y 2014-09-05 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 20 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

212008 A464 Coronary artery disease /

WORSENING

CORONARY ARTERY

DISEASE

2015-01-30 NOT RELATED

A545 Diarrhoea / DIARRHEA 2015-09-03 NOT RELATED

213007 A382 Diabetic ketoacidosis /

DIABETIC

KETOACIDOSIS

2014-05-09 NOT RELATED Y

215001 A349 Syncope / SYNCOPE 2013-07-10 2013-07-23

/ 48

UNLIKELY

A354 Cardiac death / CARDIAC

DEATH

2013-07-23

/ 48

UNLIKELY

215002 A350 Ventricular fibrillation /

VENTRICULAR

FIBRILLATION

2013-07-13 POSSIBLE

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 21 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

215009 A411 Cardiac failure congestive /

CHF EXACERBATION -

ACUTE ON CHRONIC

2014-09-07 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 22 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

215009 A459 Cardiac failure congestive /

ACUTE CONGESTIVE

HEART FAILURE

2014-11-

28/ 122

Y Y 2014-11-28 1

215013 A514 Dyspnoea / SOB 2015-05-

21/ 156

Y 2015-05-21 1

A587 Renal failure acute /

ACUTE KIDNEY INJURY

2015-11-

09/ 328

0

A586 Chest pain / ATYPICAL

CHEST PAIN

2015-11-

09/ 328

0

A584 Dizziness / DIZZINESS 2015-11-

09/ 328

Y 2015-11-09 1

217001 A366 Cardiac failure congestive /

ACUTE ON CHRONIC

SYSTOLIC

CONGESTIVE HEART

FAILURE

2013-11-

22/ 16

Y Y 2013-11-22 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 23 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A367 Cardiac failure /

WORSENING HEART

FAILURE

2013-12-

09/ 33

Y 2013-12-09 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 24 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

215009 A459 Cardiac failure congestive /

ACUTE CONGESTIVE

HEART FAILURE

2014-12-02 NOT RELATED

215013 A514 Dyspnoea / SOB 2015-05-23 NOT RELATED

A587 Renal failure acute /

ACUTE KIDNEY INJURY

2015-11-16 NOT RELATED Y

A586 Chest pain / ATYPICAL

CHEST PAIN

2015-11-16 NOT RELATED Y

A584 Dizziness / DIZZINESS 2015-11-16 NOT RELATED

217001 A366 Cardiac failure congestive /

ACUTE ON CHRONIC

SYSTOLIC

CONGESTIVE HEART

FAILURE

2013-11-25 2014-04-08

/ 153

NOT RELATED

A367 Cardiac failure /

WORSENING HEART

FAILURE

2013-12-10 2014-04-08

/ 153

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 25 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

217001 A369 Pyrexia / FEVER OF

UNKNOWN ORIGIN

2014-01-

08/ 63

Y 2014-01-08 0

A376 Septic shock / SEPTIC

SHOCK

2014-04-

01/ 146

Y 2014-04-08 Y Y 2014-04-01 2

220006 A477 Cardiac failure congestive /

WORSENING CHF

2015-03-

03/ 250

Y Y 2015-03-04 1

220008 A519 Acute coronary syndrome /

ACUTE CORONARY

SYNDROME

2015-05-

20/ 237

Y 2015-05-20 1

220009 A499 Acute myocardial

infarction / NON-ST

ELEVATION

MYOCARDIAL

INFARCTION

2015-03-

24/ 98

Y 2015-03-24 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 26 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

217001 A369 Pyrexia / FEVER OF

UNKNOWN ORIGIN

2014-01-27 2014-04-08

/ 153

NOT RELATED

A376 Septic shock / SEPTIC

SHOCK

2014-04-07 2014-04-08

/ 153

NOT RELATED

220006 A477 Cardiac failure congestive /

WORSENING CHF

2015-03-08 NOT RELATED

220008 A519 Acute coronary syndrome /

ACUTE CORONARY

SYNDROME

2015-05-21 NOT RELATED

220009 A499 Acute myocardial

infarction / NON-ST

ELEVATION

MYOCARDIAL

INFARCTION

2015-03-27 NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 27 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

221001 A425 Road traffic accident /

MANUBRIAL

FRACTURE

SECONDARY TO

MOTOR VEHICLE

ACCIDENT

2014-11-

06/ 268

Y 2014-11-06 0

221004 A504 Hypotension /

HYPOTENSION

2014-10-

09/ 1

0

A623 Cardiac failure congestive /

CONGESTIVE HEART

FAILURE

EXACERBATION

2014-10-

10/ 2

0

A505 Urinary tract infection /

URINARY TRACT

INFECTION

2014-10-

10/ 2

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 28 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

225001 A386 Cardiac perforation /

PERFORATION

REQUIRING SURGICAL

INTERVENTION

2014-05-

21/ 1

0

227002 A517 Hypotension /

HYPOTENSION

2015-04-

02/ 190

Y 2015-04-06 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 29 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

221001 A425 Road traffic accident /

MANUBRIAL

FRACTURE

SECONDARY TO

MOTOR VEHICLE

ACCIDENT

2014-11-07 NOT RELATED

221004 A504 Hypotension /

HYPOTENSION

2014-10-15 POSSIBLE Y

A623 Cardiac failure congestive /

CONGESTIVE HEART

FAILURE

EXACERBATION

2014-10-15 POSSIBLE Y

A505 Urinary tract infection /

URINARY TRACT

INFECTION

2014-10-15 UNLIKELY Y

225001 A386 Cardiac perforation /

PERFORATION

REQUIRING SURGICAL

INTERVENTION

2014-05-24 DEFINITE Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 30 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

227002 A517 Hypotension /

HYPOTENSION

2015-04-08 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 31 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

228002 A395 Angina unstable /

UNSTABLE ANGINA

2014-06-

23/ 117

Y 2014-06-23 1

A405 Angina unstable /

UNSTABLE ANGINA

2014-08-

21/ 176

Y 2014-08-21 1

A456 Angina unstable /

UNSTABLE ANGINA

2015-01-

08/ 316

Y 2015-01-08 1

228003* A421 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

SECONDARY TO

HYPOKALEMIA

2014-10-

06/ 110

Y 2014-10-06 1

A451 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2014-12-

16/ 181

Y 2014-12-16 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 32 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A476 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

SECONDARY TO

HYPOKALEMIA

2015-03-

05/ 260

Y 2015-03-05 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 33 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

228002 A395 Angina unstable /

UNSTABLE ANGINA

2014-06-25 NOT RELATED Y

A405 Angina unstable /

UNSTABLE ANGINA

2014-08-22 NOT RELATED Y

A456 Angina unstable /

UNSTABLE ANGINA

2015-01-10 NOT RELATED Y

228003* A421 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

SECONDARY TO

HYPOKALEMIA

2014-10-07 NOT RELATED

A451 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2014-12-16 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 34 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A476 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

SECONDARY TO

HYPOKALEMIA

2015-03-06 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 35 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

228003* A483 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA 2ND TO

HYPOKALEMIA

2015-04-

02/ 288

Y 2015-04-02 1

A485 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

SECONDARY TO

COCAINE ABUSE

2015-04-

03/ 289

Y 2015-04-03 1

A490 Chest pain / CHEST PAIN

WITH PALPITATIONS

2015-04-

07/ 293

Y 2015-04-07 1

A503 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2015-05-

07/ 323

Y Y 2015-05-07 1

231001 A400 Gout / ACUTE GOUT

ATTACK LEADS TO

HOSPITALIZATION

2014-07-

01/ 103

Y 2014-07-01 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 36 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A404 Renal failure acute /

ACUTE KIDNEY INJURY

2014-07-

01/ 103

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 37 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

228003* A483 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA 2ND TO

HYPOKALEMIA

2015-04-03 NOT RELATED

A485 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

SECONDARY TO

COCAINE ABUSE

2015-04-07 NOT RELATED

A490 Chest pain / CHEST PAIN

WITH PALPITATIONS

2015-04-08 NOT RELATED

A503 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2015-05-12 NOT RELATED

231001 A400 Gout / ACUTE GOUT

ATTACK LEADS TO

HOSPITALIZATION

2014-07-04 2014-09-23

/ 187

NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 38 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A404 Renal failure acute /

ACUTE KIDNEY INJURY

2014-07-04 2014-09-23

/ 187

NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 39 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

231001 A401 Ventricular tachycardia / V-

TACH

2014-07-

04/ 106

Y 2014-07-04 1

A457 Cardiac failure /

WORSENING HEART

FAILURE

2014-07-

04/ 106

0

A412 Cardiac failure /

EXACERBATION OF

HEART FAILURE

2014-09-

09/ 173

Y Y 2014-09-09 1

A414 Urinary tract infection /

UTI

2014-09-

16/ 180

Y 2014-09-23 Y 2014-09-19 2

A567 Cardiogenic shock /

CARDIOGENIC SHOCK

2014-09-

22/ 186

Y 2014-09-19 0

231006 A458 Cardiac failure acute /

ACUTE

DECOMPENSATED

HEART FAILURE

2014-11-

02/ 25

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 40 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A433 Acute myocardial

infarction / NSTEMI

2014-11-

02/ 25

Y 2014-11-02 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 41 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

231001 A401 Ventricular tachycardia / V-

TACH

2014-07-15 2014-09-23

/ 187

NOT RELATED

A457 Cardiac failure /

WORSENING HEART

FAILURE

2014-07-15 2014-09-23

/ 187

NOT RELATED Y

A412 Cardiac failure /

EXACERBATION OF

HEART FAILURE

2014-09-15 2014-09-23

/ 187

NOT RELATED

A414 Urinary tract infection /

UTI

2014-09-23 2014-09-23

/ 187

NOT RELATED

A567 Cardiogenic shock /

CARDIOGENIC SHOCK

2014-09-23 2014-09-23

/ 187

NOT RELATED

231006 A458 Cardiac failure acute /

ACUTE

DECOMPENSATED

HEART FAILURE

2014-11-04 NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 42 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A433 Acute myocardial

infarction / NSTEMI

2014-11-04 UNLIKELY Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 43 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

231006 A559 Cerebrovascular accident /

STROKE

2015-07-

19/ 284

Y 2015-07-19 1

231014 A564 Fall / FALL AT HOME 2014-12-

16/ 27

Y 2014-12-16 0

A472 Chest pain / CHEST PAIN

SECONDARY TO MICRO

VASCULAR DISEASE

2015-02-

14/ 87

Y 2015-02-14 1

A568 Chest pain / CHEST PAIN 2015-03-

09/ 110

Y 2015-03-09 1

A592 Hypokalaemia / SEVERE

HYPOKALEMIA

2015-03-

09/ 110

0

A569 Chest pain / CHEST PAIN 2015-06-

13/ 206

Y 2015-06-15 1

A570 Cardiac failure / ACUTE

ON CHRONIC SYSTOLIC

HEART FAILURE

2015-09-

02/ 287

Y 2015-09-02 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 44 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A590 Chest pain / CHEST PAIN 2015-09-

02/ 287

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 45 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

231006 A559 Cerebrovascular accident /

STROKE

2015-07-21 NOT RELATED Y

231014 A564 Fall / FALL AT HOME 2014-12-18 NOT RELATED

A472 Chest pain / CHEST PAIN

SECONDARY TO MICRO

VASCULAR DISEASE

2015-02-16 NOT RELATED

A568 Chest pain / CHEST PAIN 2015-03-11 NOT RELATED

A592 Hypokalaemia / SEVERE

HYPOKALEMIA

2015-03-11 NOT RELATED Y

A569 Chest pain / CHEST PAIN 2015-06-16 NOT RELATED

A570 Cardiac failure / ACUTE

ON CHRONIC SYSTOLIC

HEART FAILURE

2015-09-05 NOT RELATED

A590 Chest pain / CHEST PAIN 2015-09-05 NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 46 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

233002 A406 Non-cardiac chest pain /

NON-CARDIAC CHEST

PAIN

2014-07-

11/ 16

Y 2014-07-11 1

A596 Angina unstable /

UNSTABLE ANGINA

2015-05-

31/ 340

Y 2015-05-31 1

235001 A546 Cardiac failure congestive /

ACUTE ON CHRONIC

CHF

2015-07/ Y Y 2015-08-02 1

A594 Hypotension /

HYPOTENSION

2014-08-

14/ 1

0

A595 Bronchopneumonia /

MULTILOBAR

BRONCHOPNEUMONIA

2015-03-

26/ 225

Y Y 2015-03-29 1

237001 A431 Cardiac failure /

WORSENING HEART

FAILURE

2014-09-

16/ 105

Y Y 2014-09-16 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 47 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A487 Cardiac failure /

WORSENING HEART

FAILURE

2015-03-

30/ 300

Y 2015-04-04 Y Y 2015-03-30 2

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 48 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

233002 A406 Non-cardiac chest pain /

NON-CARDIAC CHEST

PAIN

2014-07-12 NOT RELATED

A596 Angina unstable /

UNSTABLE ANGINA

2015-06-01 NOT RELATED

235001 A546 Cardiac failure congestive /

ACUTE ON CHRONIC

CHF

2015-08-04 NOT RELATED

A594 Hypotension /

HYPOTENSION

PROBABLE Y

A595 Bronchopneumonia /

MULTILOBAR

BRONCHOPNEUMONIA

2015-03-31 NOT RELATED

237001 A431 Cardiac failure /

WORSENING HEART

FAILURE

2014-09-21 2015-04-04

/ 305

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 49 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A487 Cardiac failure /

WORSENING HEART

FAILURE

2015-04-04 2015-04-04

/ 305

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 50 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

237001 A572 Acute respiratory failure /

ACUTE RESPIRATORY

FAILURE

2015-03-

31/ 301

0

A516 Pulseless electrical activity

/ PULSELESS

ELECTRICAL ACTIVITY

2015-03-

31/ 301

0

A549 Cardio-respiratory arrest /

CARDIOPULMONARY

ARREST

2015-04-

04/ 305

0

237002 A468 Syncope / SYNCOPAL

EPISODE SECONDARY

TO ELECTROLYTE

IMBALANCE

2014-12-

11/ 140

Y 2014-12-11 1

A515 Ventricular fibrillation /

VENTRICULAR

FIBRILLATION

2014-12-

11/ 140

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 51 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

237001 A572 Acute respiratory failure /

ACUTE RESPIRATORY

FAILURE

2015-04-03 2015-04-04

/ 305

NOT RELATED Y

A516 Pulseless electrical activity

/ PULSELESS

ELECTRICAL ACTIVITY

2015-04-04 2015-04-04

/ 305

NOT RELATED Y

A549 Cardio-respiratory arrest /

CARDIOPULMONARY

ARREST

2015-04-04

/ 305

NOT RELATED Y

237002 A468 Syncope / SYNCOPAL

EPISODE SECONDARY

TO ELECTROLYTE

IMBALANCE

2014-12-13 NOT RELATED

A515 Ventricular fibrillation /

VENTRICULAR

FIBRILLATION

2014-12-13 NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 52 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

237007 A465 Bronchitis / BRONCHITIS 2014-12-

14/ 40

Y 2014-12-14 0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 53 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Control

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

237007 A465 Bronchitis / BRONCHITIS 2014-12-16 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 54 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

201009 A593 Osteoarthritis / LEFT

KNEE DEGENERATIVE

JOINT DISEASE

2014-12-

17/ 44

Y 2014-12-17 0

202004 A500 Cardiac failure chronic /

WORSENING HEART

FAILURE

2015-02-

25/ 181

Y 2015-04-20 2015-04-21 1

A563 Fluid overload / VOLUME

OVERLOAD

2015-04-

22/ 237

0

204003 A543 Gastrointestinal

haemorrhage /

GASTROINTESTINAL

BLEED

2015-08/ 0

A562 Cardiac failure chronic /

ACUTE ON CHRONIC

SYSTOLIC HEART

FAILURE

2015-08-

25/ 208

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 55 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A544 Small intestine carcinoma /

DUODENAL

CARCINOID

2015-08-

26/ 209

Y 2015-08-22 0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 56 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

201009 A593 Osteoarthritis / LEFT

KNEE DEGENERATIVE

JOINT DISEASE

2014-12-19 NOT RELATED

202004 A500 Cardiac failure chronic /

WORSENING HEART

FAILURE

2015-05-08 2015-04-22

/ 237

NOT RELATED

A563 Fluid overload / VOLUME

OVERLOAD

2015-05-08 2015-04-22

/ 237

NOT RELATED Y

204003 A543 Gastrointestinal

haemorrhage /

GASTROINTESTINAL

BLEED

2015-08-28 NOT RELATED Y

A562 Cardiac failure chronic /

ACUTE ON CHRONIC

SYSTOLIC HEART

FAILURE

2015-08-28 NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 57 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A544 Small intestine carcinoma /

DUODENAL

CARCINOID

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 58 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

204003 A557 Gastrointestinal

haemorrhage /

GASTROINTESTINAL

BLEED

2015-09-

25/ 239

Y 2015-09-28 0

205001 A392 Gastroenteritis viral /

VIRAL

GASTROENTERITIS

2014-04-

20/ 54

Y 2014-04-20 0

207002 A330 Nephropathy toxic /

CONTRAST DYE

INDUCED

NEPHROPATHY

2013-04-

19/ 2

Y 2013-04-19 0

Dyspnoea / WORSENING

SHORTNESS OF

BREATH

2013-04-

29/ 12

2013-04-29 1

A333 Renal failure acute /

ACUTE KIDNEY INJURY

2013-05-

27/ 40

Y 2013-05-27 0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 59 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A348 Cardiac failure congestive /

EXACERBATION OF

CONGESTIVE HEART

FAILURE

2013-07-

04/ 78

Y Y 2013-07-04 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 60 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

204003 A557 Gastrointestinal

haemorrhage /

GASTROINTESTINAL

BLEED

2015-10-04 NOT RELATED

205001 A392 Gastroenteritis viral /

VIRAL

GASTROENTERITIS

2014-04-21 NOT RELATED

207002 A330 Nephropathy toxic /

CONTRAST DYE

INDUCED

NEPHROPATHY

2013-04-23 DEFINITE

Dyspnoea / WORSENING

SHORTNESS OF

BREATH

NOT RELATED

A333 Renal failure acute /

ACUTE KIDNEY INJURY

2013-06-01 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 61 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A348 Cardiac failure congestive /

EXACERBATION OF

CONGESTIVE HEART

FAILURE

2013-07-11 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 62 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

207002 A355 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

EXACERBATION

2013-07-

24/ 98

Y 2013-07-25 1

207004 A378 Pericardial effusion /

PERICARDIAL

EFFUSION

2014-04-

10/ 1

0

A379 Cardiac tamponade /

CARDIAC TAMPONADE

2014-04-

20/ 11

Y 2014-04-20 1

208001 A410 Syncope / SYNCOPE AND

COLLAPSE

2014-08-

24/ 201

Y 2014-08-29 1

210003 A621 Hypotension /

HYPOTENSION

2014-04-

02/ 1

0

A375 Femoral artery dissection /

RIGHT FEMORAL

DISSECTION

2014-04-

02/ 1

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 63 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A547 Cardiac failure acute /

ACUTE

DECOMPENSATED

HEART FAILURE

2015-04-

01/ 365

Y Y 2015-04-01 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 64 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

207002 A355 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

EXACERBATION

2013-07-29 NOT RELATED

207004 A378 Pericardial effusion /

PERICARDIAL

EFFUSION

2014-04-15 DEFINITE Y

A379 Cardiac tamponade /

CARDIAC TAMPONADE

2014-04-25 PROBABLE

208001 A410 Syncope / SYNCOPE AND

COLLAPSE

2014-09-10 NOT RELATED

210003 A621 Hypotension /

HYPOTENSION

2014-04-06 POSSIBLE Y

A375 Femoral artery dissection /

RIGHT FEMORAL

DISSECTION

2014-04-06 DEFINITE Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 65 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A547 Cardiac failure acute /

ACUTE

DECOMPENSATED

HEART FAILURE

2015-04-14 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 66 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

211002 A509 Peripheral vascular disorder

/ WORSENING PVD

2014-08-

04/ 91

0

A449 Osteomyelitis / LEFT

FOOT OSTEOMYELITIS

2014-12-

11/ 220

Y 2014-12-11 1

211007 A488 Dehydration /

DEHYDRATION

2015-04-

07/ 188

Y 2015-04-07 1

212002 A370 Influenza / INFLUENZA A 2014-01-

24/ 227

Y 2014-01-26 0

212006 A536 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2015-05-

09/ 284

Y 2015-05-09 1

A542 Gastrointestinal

haemorrhage / GI BLEED

2015-06-

30/ 336

Y 2015-06-30 0

215003 A388 Renal failure chronic /

ESKD

2013-12-

30/ 83

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 67 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A368 Cardiac failure /

WORSENING HEART

FAILURE

2013-12-

30/ 83

Y Y 2013-12-30 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 68 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

211002 A509 Peripheral vascular disorder

/ WORSENING PVD

2014-09-09 NOT RELATED Y

A449 Osteomyelitis / LEFT

FOOT OSTEOMYELITIS

2014-12-30 NOT RELATED

211007 A488 Dehydration /

DEHYDRATION

2015-04-11 NOT RELATED

212002 A370 Influenza / INFLUENZA A 2014-01-30 NOT RELATED Y

212006 A536 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2015-05-11 NOT RELATED

A542 Gastrointestinal

haemorrhage / GI BLEED

2015-07-04 NOT RELATED

215003 A388 Renal failure chronic /

ESKD

2014-01-11 NOT RELATED Y

A368 Cardiac failure /

WORSENING HEART

FAILURE

2014-01-11 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 69 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

215004 A384 Cardiac failure congestive /

CHF EXACERBATION

2014-04-

10/ 128

Y Y 2014-04-10 1

A383 Acute myocardial

infarction / ACUTE NON-

ST ELEVATION

MYOCARDIAL

INFARCTION

2014-04-

26/ 144

Y 2014-04-26 1

215007 A407 Supraventricular

tachycardia /

RECURRENT

SUPRAVENTRICULAR

TACHYCARDIA

2014-08-

20/ 71

Y 2014-08-20 1

A471 Coronary artery disease /

WORSENING

CORONARY ARTERY

DISEASE

2015-01-

18/ 222

Y 2015-01-18 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 70 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

220007 A533 Cardiac failure congestive /

WORSENING CHF -

CONGESTIVE HEART

FAILURE

2015-06-

03/ 272

Y 2015-06-11 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 71 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

215004 A384 Cardiac failure congestive /

CHF EXACERBATION

2014-04-12 NOT RELATED

A383 Acute myocardial

infarction / ACUTE NON-

ST ELEVATION

MYOCARDIAL

INFARCTION

2014-04-30 NOT RELATED Y

215007 A407 Supraventricular

tachycardia /

RECURRENT

SUPRAVENTRICULAR

TACHYCARDIA

2014-08-23 NOT RELATED

A471 Coronary artery disease /

WORSENING

CORONARY ARTERY

DISEASE

2015-01-30 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 72 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

220007 A533 Cardiac failure congestive /

WORSENING CHF -

CONGESTIVE HEART

FAILURE

2015-06-12 NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 73 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point a221005 A489 Myocardial infarction /

NON-Q-WAVE

MYOCARDIAL

INFARCTION

2015-04-

10/ 165

Y 2015-04-10 1

A511 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2015-05-

18/ 203

Y 2015-05-18 1

A539 Cardiogenic shock /

CARDIOGENIC SHOCK

DUE TO VENTRICULAR

TACHYCARDIA

2015-05-

20/ 205

Y 2015-05-18 1

A520 Ventricular tachycardia /

INCESSANT

RECURRING

VENTRICULAR

TACHYCARDIA

2015-06-

03/ 219

Y 2015-06-16 Y Y 2015-06-03 2015-06-07 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 74 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A540 Ventricular tachycardia /

MONOMORPHIC

VENTRICULAR

TACHYCARDIA

2015-06-

04/ 220

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 75 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event a221005 A489 Myocardial infarction /

NON-Q-WAVE

MYOCARDIAL

INFARCTION

2015-04-12 2015-06-16

/ 232

2015-06-09

/ 225

NOT RELATED Y

A511 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2015-05-29 2015-06-16

/ 232

2015-06-09

/ 225

POSSIBLE

A539 Cardiogenic shock /

CARDIOGENIC SHOCK

DUE TO VENTRICULAR

TACHYCARDIA

2015-05-29 2015-06-16

/ 232

2015-06-09

/ 225

POSSIBLE

A520 Ventricular tachycardia /

INCESSANT

RECURRING

VENTRICULAR

TACHYCARDIA

2015-06-07 2015-06-16

/ 232

2015-06-09

/ 225

POSSIBLE

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 76 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A540 Ventricular tachycardia /

MONOMORPHIC

VENTRICULAR

TACHYCARDIA

2015-06-07 2015-06-16

/ 232

2015-06-09

/ 225

NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 77 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

221007 A599 Pneumonia /

PNEUMONIA

2015-12-

15/ 364

Y Y 2015-12-18 0

222003 A439 Ischaemic stroke / ACUTE

ISCHEMIC INFARCT

2014-11-

18/ 153

Y 2014-11-19 1

222006 A442 Cardiogenic shock /

CARDIOGENIC SHOCK

2014-12-

04/ 64

Y Y 2014-12-04 1

A482 Cardiac failure /

DECOMPENSATED

HEART FAILURE

2015-01-

31/ 122

Y Y 2015-01-31 2015-03-06 1

a221005 A541 Cardiac arrest / CARDIAC

ARREST DUE TO

VENTRICULAR

TACHYCARDIA AND

VENTRICULAR

FIBRILLATION

2015-06-

09/ 225

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 78 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A598 Cardiac arrest / CARDIAC

ARREST DUE TO

VENTRICULAR

TACHYCARDIA

2015-06-

12/ 228

0

A522 Cardiogenic shock /

CARDIOGENIC SHOCK

2015-06-

16/ 232

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 79 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

221007 A599 Pneumonia /

PNEUMONIA

2015-12-20 POSSIBLE

222003 A439 Ischaemic stroke / ACUTE

ISCHEMIC INFARCT

2014-11-20 NOT RELATED Y

222006 A442 Cardiogenic shock /

CARDIOGENIC SHOCK

2014-12-08 2015-03-06 /

156

NOT RELATED

A482 Cardiac failure /

DECOMPENSATED

HEART FAILURE

2015-03-16 2015-03-06 /

156

NOT RELATED

a221005 A541 Cardiac arrest / CARDIAC

ARREST DUE TO

VENTRICULAR

TACHYCARDIA AND

VENTRICULAR

FIBRILLATION

2015-06-16 2015-06-16

/ 232

2015-06-09

/ 225

POSSIBLE Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 80 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A598 Cardiac arrest / CARDIAC

ARREST DUE TO

VENTRICULAR

TACHYCARDIA

2015-06-16 2015-06-16

/ 232

2015-06-09

/ 225

POSSIBLE Y

A522 Cardiogenic shock /

CARDIOGENIC SHOCK

2015-06-16 2015-06-16

/ 232

2015-06-09

/ 225

POSSIBLE Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 81 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

223002 Fluid overload / CHF

FLUID OVERLOAD

2014-03-

31/ 14

2014-03-31 1

A387 Chest pain / CHEST PAIN 2014-04-

26/ 40

Y 2014-04-26 1

A452 Chest pain / CHEST PAIN 2014-05-

01/ 45

Y 2014-05-01 1

A453 Syncope / SYNCOPE 2014-06-

17/ 92

Y 2014-06-17 1

224003 A618 Ventricular tachycardia /

RECURRENT

VENTRICULAR

TACHYCARDIA

2015-12/ 0

A523 Cardiac failure /

WORSENING HEART

FAILURE

2015-05-

12/ 104

Y 2015-05-12 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 82 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A608 Cardiac failure /

WORSENING HEART

FAILURE

2015-11-

30/ 306

Y 2016-01-03 Y 2015-11-30 2

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 83 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

223002 Fluid overload / CHF

FLUID OVERLOAD

NOT RELATED

A387 Chest pain / CHEST PAIN 2014-04-29 NOT RELATED

A452 Chest pain / CHEST PAIN 2014-05-02 NOT RELATED

A453 Syncope / SYNCOPE 2014-06-22 NOT RELATED Y

224003 A618 Ventricular tachycardia /

RECURRENT

VENTRICULAR

TACHYCARDIA

2016-01-03 2016-01-03

/ 340

NOT RELATED Y

A523 Cardiac failure /

WORSENING HEART

FAILURE

2015-05-14 2016-01-03

/ 340

NOT RELATED

A608 Cardiac failure /

WORSENING HEART

FAILURE

2016-01-03 2016-01-03

/ 340

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 84 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

228007 A538 Femur fracture /

FRACTURED FEMUR

2015-07-

17/ 295

Y 2015-07-17 0

A573 Coagulopathy /

COUMADIN INDUCED

COAGULOPATHY

2015-08-

21/ 330

Y 2015-08-21 0

229002 A486 Ventricular tachycardia /

PAROXSYMAL

VENTRICULAR

TACHYCARDIA

(TERMINATED BY ICD)

WHICH

CORRESPONDED TO

PATIENT'S SYNCOPAL

EPISODE

2015-04-

05/ 109

Y Y 2015-04-05 1

A498 Cardiac failure acute /

ACUTE ON CHRONIC

SYSTOLIC HEART

FAILURE

2015-04-

13/ 117

Y Y 2015-04-15 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 85 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A513 Cardiac failure congestive /

CONGESTIVE HEART

FAILURE

2015-05-

15/ 149

Y 2015-05-15 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 86 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

228007 A538 Femur fracture /

FRACTURED FEMUR

2015-07-20 NOT RELATED

A573 Coagulopathy /

COUMADIN INDUCED

COAGULOPATHY

2015-08-23 NOT RELATED

229002 A486 Ventricular tachycardia /

PAROXSYMAL

VENTRICULAR

TACHYCARDIA

(TERMINATED BY ICD)

WHICH

CORRESPONDED TO

PATIENT'S SYNCOPAL

EPISODE

2015-04-08 2015-05-15

/ 149

NOT RELATED

A498 Cardiac failure acute /

ACUTE ON CHRONIC

SYSTOLIC HEART

FAILURE

2015-04-27 2015-05-15

/ 149

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 87 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A513 Cardiac failure congestive /

CONGESTIVE HEART

FAILURE

2015-05-15

/ 149

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 88 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

231012 Fluid overload /

VOLUME/FLUID

OVERLOAD

2015-09-

28/ 321

0

A580 Cardiac failure congestive /

EXACERBATION OF

CONGESTIVE HEART

FAILURE

2015-10-

27/ 350

Y Y 2015-10-27 1

231013 A475 Cardiac failure acute /

ACUTE

DECOMPENSATED

HEART FAILURE

2015-02-

22/ 67

Y Y 2015-02-26 1

A479 Cardiac failure acute /

ACUTE

DECOMPENSATED

HEART FAILURE

2015-03-

12/ 85

Y Y 2015-03-17 1

A484 Cardiogenic shock /

CARDIOGENIC SHOCK

2015-03-

30/ 103

Y Y 2015-03-31 2015-04-21 1

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 89 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

A532 Haemorrhage intracranial /

INTRACRANIAL

HEMORRHAGE

2015-07-

10/ 205

Y 2015-07-11 Y 2015-07-10 0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 90 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

231012 Fluid overload /

VOLUME/FLUID

OVERLOAD

NOT RELATED Y

A580 Cardiac failure congestive /

EXACERBATION OF

CONGESTIVE HEART

FAILURE

2015-10-31 NOT RELATED

231013 A475 Cardiac failure acute /

ACUTE

DECOMPENSATED

HEART FAILURE

2015-03-09 2015-07-11

/ 206

2015-04-21

/ 125

NOT RELATED

A479 Cardiac failure acute /

ACUTE

DECOMPENSATED

HEART FAILURE

2015-03-25 2015-07-11

/ 206

2015-04-21

/ 125

NOT RELATED

A484 Cardiogenic shock /

CARDIOGENIC SHOCK

2015-05-08 2015-07-11

/ 206

2015-04-21

/ 125

NOT RELATED

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 91 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

A532 Haemorrhage intracranial /

INTRACRANIAL

HEMORRHAGE

2015-07-11 2015-07-11

/ 206

2015-04-21

/ 125

NOT RELATED Y

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 92 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

231015* A512 Cardiac failure congestive /

EXACERBATION OF

CONGESTIVE HEART

FAILURE

2015-05-

05/ 97

Y Y 2015-05-05 1

A610 Cardiac failure / ACUTE

SYSTOLIC HEART

FAILURE

2015-05-

13/ 105

Y Y 2015-05-13 1

A606 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

2015-05-

13/ 105

0

A609 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

ARREST

2015-05-

18/ 110

0

A566 Cardiac failure congestive /

EXACERBATION OF

CONGESTIVE HEART

FAILURE

2015-09-

07/ 222

0

Protocol ixCELL-55-1202-1 Top Line Report

Listing 16.2.6.1 Adjudication Events (Treated Set)

CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction

*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.

#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.

Vericel Corporation CONFIDENTIAL Page 93 of 103

Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf

Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

231015* A512 Cardiac failure congestive /

EXACERBATION OF

CONGESTIVE HEART

FAILURE

2015-05-10 NOT RELATED

A610 Cardiac failure / ACUTE

SYSTOLIC HEART

FAILURE

2015-05-28 NOT RELATED

A606 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

NOT RELATED Y

A609 Ventricular tachycardia /

VENTRICULAR

TACHYCARDIA

ARREST

2015-05-28 NOT RELATED Y

A566 Cardiac failure congestive /

EXACERBATION OF

CONGESTIVE HEART

FAILURE

2015-09-13 NOT RELATED Y

Actual Treatment: Ixmyelocel-T

Start Adjudication Results Prim

Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End

ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point

233006 A438 Cardiac failure congestive /

WORSENING CHF

2014-11-

21/ 2

Y 2014-11-20 1

235002 A434 Chest pain / CHEST PAIN

(ON LEFT SIDE)

2014-11-

06/ 92

Y 2014-11-10 1

Actual Treatment: Ixmyelocel-T

Subject SAE Preferred /

Hospital

Discharge Un-adjudicated Dates / Study Day

Related to

Catheterization- Additional Adjudication Results

ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event

233006 A438 Cardiac failure congestive /

WORSENING CHF

2014-11-22 NOT RELATED

235002 A434 Chest pain / CHEST PAIN

(ON LEFT SIDE)

2014-11-11 NOT RELATED

IxCELL-DCM Trial Investigators

R. David Anderson, MD

University of Florida

Gainesville, FL

Adam Berman, MD

Georgia Regents University

Augusta, GA

Eugene Chung, MD

The Christ Hospital Lindner Center for Research and Education

Cincinnati, OH

Anthony DeMaria, MD

University of California, San Diego

San Diego, CA

Nabil Dib, MD

Mercy Gilbert Medical Center

Phoenix, AZ

Cara East, MD

Clinical Cardiovascular Research Center

Baylor University Medical Center

Dallas, TX

F. David Fortuin, MD

Mayo Clinic

Phoenix, AZ

Jon George, MD

Temple University School of Medicine

Philadelphia, PA

Joshua Hare, MD

University of Miami Miller School of Medicine

Miami, FL

David Henderson, MD

Cardiology Research Associates

Daytona Beach, FL

Timothy Henry, MD

Cedars-Sinai Heart Institute

Los Angeles, CA

Paul Huang, MD

Swedish Medical Center

Seattle, WA

Safwan Kassas, MD

Michigan Cardiovascular Institute

Saginaw, MI

Frank McGrew, MD

Stern Cardiovascular Foundation

Germantown, TN

Kimberly Parks, DO

Massachusetts General Hospital

Boston, MA

Amit N Patel, MD MS

University of Utah School of Medicine

Salt Lake City, UT

Sumanth Prabhu, MD

University of Alabama at Birmingham School of Medicine

Birmingham, AL

Rajan Patel, MD

Ochsner Medical Center

New Orleans, LA

Arshed Quyyumi, MD

Emory University School of Medicine

Atlanta, GA

Amish Raval, MD

University of Wisconsin School of Medicine and Public Health

Madison, WI

Guy Reeder, MD

Alfredo Clavell, MD

Mayo Clinic

Rochester, MN

Gary Schaer, MD

Rush University Medical Center

Chicago, IL

Richard Schatz, MD

Scripps Clinic

San Diego, CA

David Schmidt, MD

St. John’s Regional Medical Center

Oxnard, CA

P. Christian Schulze, MD, PhD

Columbia University

New York, NY

Catalin Toma, MD

University of Pittsburgh Medical Center

Pittsburgh, PA

Barry Trachtenberg, MD

Houston Methodist Hospital

Houston, TX

Mark Zucker, MD

Newark Beth Israel Medical Center

Newark, NJ

Participating Investigators who did not randomize any patients into the ixCELL-DCM trial:

Joe Wu, MD, PhD

Stanford University School of Medicine

Stanford, CA

(Screened 2 patients)

Guilherme Oliveira, MD

University Hospitals Case Medical Center

Cleveland, OH

(Screened 2 patients)

Hung Ly, MD

Montreal Heart Institute

Montreal, Quebec, Canada

(Screened 1 patient)

Robert Welsh, MD

University of Alberta

Edmonton, Alberta, Canada

(Screened 0 patients)

Dropped out of Trial:

David Feldman, MD

Minneapolis Heart Institute

Minneapolis, MN

IxCELL-DCM Study Steering Committee

Amit N. Patel, MD MS– Steering Committee Chairman

Associate Professor, Division of Cardiothoracic Surgery

University of Utah School of Medicine

Director, Clinical Regenerative Medicine and Tissue Engineering

University of Utah

Timothy D. Henry, MD - PI

Department of Medicine

Director, Division of Cardiology

Lee and Harold Kapelovitz Chair in Research Cardiology

Cedars-Sinai Heart Institute

Cedars-Sinai Medical Center

Anthony N. DeMaria, MD

Professor of Medicine

Judith and Jack White Chair in Cardiology

University of California, San Diego

Gary L. Schaer, MD

Professor of Medicine

Director, Cardiology Research and Strategic Development

Rush University Medical Center

David P. Recker, MD

Chief Medical Officer

Vericel Corporation

IxCELL-DCM Study Data Safety Monitoring Board (DSMB)

David D. Waters, MD – DSMB Chairman

Professor Emeritus Department of Medicine

University of California, San Francisco

Marc A. Pfeffer, MD, PhD

Cardiovascular Division, Brigham and Women’s Hospital and

Victor J. Dzau Professor of Medicine, Harvard Medical School

Nelson J. Chao, MD, MBA

Professor of Medicine and Immunology

Chief, Division of Hematological Malignancies and the Division of Cellular Therapy/Bone Marrow Transplant

Duke University

Cathie Leister, MS

Pharmaceutical Biostatistician

Independent Consultant

IxCELL-DCM Study Clinical Endpoint Adjudication

Brigham and Women’s Hospital Clinical Endpoint Center (CEC)

Akshay S. Desai, MD, MPH – CEC Committee Chairman

Associate Director Brigham Cardiovascular Consultants

Brigham and Women’s Hospital

Assistant Professor, Harvard Medical School

Peter V. Finn MD (physician reviewer) Cardiovascular Consultants

Brigham and Women’s Hospital

Assistant Professor, Harvard Medical School

L. Howard Hartley MD (physician reviewer) Cardiovascular Consultants

Brigham and Women’s Hospital

Assistant Professor, Harvard Medical School

IxCELL-DCM Study Statistics Core

Fang Dong – Clinical Programming Support – Vericel Corp

John Ilgenfritz – Independent Statistician

Jian Jing, PhD – Study Design & Biostatistics Center

University of Utah School Medicine

Mathew Brobeck - University of Utah School Medicine

Courtney Bartlett - University of Utah School Medicine

Amalia A. Winters - University of Utah School Medicine