Download - CITR Annual Report Exhibits
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CITR Annual Report ExhibitsCollaborative Islet Transplant Registry (CITR)
2009 Annual ReportExhibits
Prepared by:
CITR Coordinating CenterThe EMMES Corporation
Rockville, MD
Sponsored by:National Institute of Diabetes & Digestive & Kidney Diseases
National Institutes of HealthJuvenile Diabetes Research Foundation
Datafile Closure: April 1, 2009
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Collaborative Islet Transplant Registry 2009.Follow-up time after initial infusion for each recipient. Top: islet after kidney (N=65), bottom: islet alone (N=347).
Yellow: insulin independence; green: insulin-using with graft function (70% average reduction in daily insulin use from baseline); black: no islet function; gray: missing data. Red marks indicate reinfusions.
Pie charts show percent of all follow-up time with insulin independence.
Insulin Dependent46.5
Insulin Independent17.6
No Data15.0
No Graft Function20.8
Insulin Dependent37.9
Insulin Independent25.9
No Data14.5
No Graft Function21.6
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Table of Contents
Chapter 1: Islet Transplant Activity
Chapter 2: Recipient and Donor Characteristics
Chapter 3: Pancreas Procurement, Islet Processing, and Infusion
Characteristics
Chapter 4: Immunosuppression and Other Medications
Chapter 5: Graft Function
Chapter 6: Liver, Kidney, Lipid, and PRA Effects
Chapter 7: Adverse Events
Chapter 8: Registry Data Quality Review
CITR Coordinating Center
CITR Committees
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Chapter 1: Islet Transplant Activity
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Islet Transplant Centers Reporting Data to CITR:Participating North American Centers 1999-2008
A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008C - CITR Centers with no islet allograft infusions in 2008D - CITR Coordinating Center
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Islet Transplant Centers Reporting Data to CITRParticipating European Centers 1999-2008
A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008B - CITR Centers with data reports pending
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Islet Transplant Centers Reporting Data to CITRParticipating Australian Centers 1999-2008
A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008C - CITR Centers with no islet allograft infusions in 2008
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Number of Islet Transplantation Centers Performing Islet Allografts per Year and Number with Data Entered in CITR Database
All North American Islet Transplant Centers 1999-2008
All North American Centers Performing Islet Allografts (N=32)CITR-Participating Centers with Data Entered (N=27)
6
2
9
6
16
11
14
11
20
16
23
20
1615
109
1514
Num
ber o
f Cen
ters
0
5
10
15
20
25
1999-2000 2001 2002 2003 2004 2005 2006 2007 2008
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Total Number of Islet Allograft Recipients, Recipients at CITR-Participating Centers, and Recipients with Detailed Data Reported to CITR by Year of First Islet Allograft Infusion
All North American Islet Transplant Centers 1999-2008
The Islet Transplant Summary (ITS) questionnaire is completed by all North American Islet Transplant Programs regardless of their participation in the Registry. Of 46 North American islet transplant programs polled, all have provided this information through 2007.
All North American Recipients (N=408)All North American CITR Recipients (N=368)Recipients with Detailed Data Reported to CITR (N=329)
30 30
15
45 44
36
8275
71
4538 37
53
4541
6558 55
3631 30
20 19 19
3228
25
Num
ber o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
1999-2000 2001 2002 2003 2004 2005 2006 2007 2008
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Total Number of Islet Allograft Recipients and Recipients with Detailed Data Reported to CITR by Year of First Islet Allograft Infusion
CITR-Participating European and Australian JDRF Centers 1999-2008
All European and Australian CITR Recipients (N=183)Recipients with Detailed Data Reported to CITR (N=83)
36
47
1
25
7
16
12
22
10
23
13
21
1316
12
17
11
Num
ber o
f Pro
cedu
res
0
5
10
15
20
25
30
35
40
1999-2000 2001 2002 2003 2004 2005 2006 2007 2008
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Total Number of Islet Allograft Infusion Procedures Performed andNumber with Data Reported to CITR
CITR-Participating North American Islet Transplant Centers 1999-2008
All Infusions for North American Recipients (N=783)All Infusions for North American CITR Recipients (N=694)Infusions with Data Reported to CITR (N=637)
50 50
31
64 63
49
142132
125
106
91 88
110
9587
125113109
7865 65
4234 34
66
51 49
Num
ber o
f Pro
cedu
res
0
20
40
60
80
100
120
140
160
1999-2000 2001 2002 2003 2004 2005 2006 2007 2008
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Total Number of Islet Allograft Infusion Procedures Performed and Number with Data Reported to CITR
CITR-Participating European and Australian JDRF Centers 1999-2008
All Infusions for European and Australian CITR Recipients (N=326)Infusions with Data Reported to CITR (N=182)
50
912
4
38
12
34
27
42
24
52
32
43
29 28
22
2723
Num
ber o
f Pro
cedu
res
0
10
20
30
40
50
60
1999-2000 2001 2002 2003 2004 2005 2006 2007 2008
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Total Number (N=828) of Islet Allograft Infusion Procedures Conducted andEntered in CITR Database, by Year and Infusion Procedure NumberCITR-Participating North American and JDRF Centers, 1999-2008
First infusionSecond InfusionThird InfusionFourth Infusion
4053
137
115 111
141
94
56
72
9Num
ber o
f Isl
et In
fusi
ons
015
30
45
6075
90
105120
135
150
1999-2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
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Number (N=828) of Islet Allograft Infusion Procedures Per Recipient:CITR-Participating North American and JDRF Centers, 1999-2008
Islet Alone RecipientsIslet After Kidney Recipients
107
202
95
8
Num
ber o
f Rec
ipie
nts
020406080
100120140160180200220
Total Number of Infusions Received1 2 3 4
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Total Number (N=905) of Deceased Donors per Islet Allograft Infusion ProcedureCITR-Participating North American and JDRF Centers, 1999-2008
754
71
3
Num
ber o
f Isl
et A
llogr
aft I
nfus
ions
050
100150200250300350400450500550600650700750800
Total Number of Donors Received1 2 3
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Islet Alone and Islet After Kidney RecipientsCITR-Participating North American and JDRF Centers, 1999-2008
Islet Alone347
Islet After Kidney65
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Chapter 2: Recipient and Donor Characteristics
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Recipient Demographics
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Transplant Recipient Primary Funding InformationCITR-Participating US Centers
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Recipient Characteristics at First Infusion
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Recipient Diabetes Characteristics at First Infusion
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Recipient Autoantibodies at First Infusion
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Recipient Infectious Disease Testing at First Infusion
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Recipient Characteristics at First Infusion by Total Number of Infusions Received
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Recipient Demographics and Characteristics at First Infusionby Total Number of Infusions Received
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Recipient Laboratory Values at First Infusion
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Donor DemographicsAll Allograft Donors
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Donor CharacteristicsAll Allograft Donors
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Donor CharacteristicsAll Allograft Donors (continued)
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Characteristics of Organ Procurement and Donor Cause of DeathAll Allograft Donors
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Treatments Given to Donor During HospitalizationAll Allograft Donors
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Treatments Given to Donor During HospitalizationAll Allograft Donors (continued)
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Donor SerologyAll Allograft Donors
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Donor Laboratory DataAll Allograft Donors
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Organ Crossmatch ResultsAll Allograft Donors
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Chapter 3: Pancreas Procurement, Islet processing and Infusion Characteristics
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Pancreas Procurement and Islet Processing
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Pancreas Procurement and Islet Processing (continued)
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Cold Ischemia Information
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Islet Equivalents and Timing of Count
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Islet Product Characterization
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Islet Product and Infusion Characteristics by Infusion Sequence
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Univariate Analysis of Islet Characteristicsby Pancreas Preservation Method
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Significant Relationships (p<0.05) between Islet Outcomes and Categorical PredictorsUnivariate Analysis
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Significant Relationships (p<0.05) between Islet Outcomes and Categorical PredictorsUnivariate Analysis (continued)
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Significant Relationships (p<0.05) between Islet Outcomes and Categorical PredictorsUnivariate Analysis (continued)
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Significant Relationships (p<0.05) between Islet Outcomes and Categorical PredictorsUnivariate Analysis (continued)
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Univariate Correlation of Islet Characteristics with Donor, Recovery, and Processing Characteristics
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Univariate Correlation of Islet Characteristics with Donor, Recovery, and Processing Characteristics (continued)
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Univariate Correlation of Islet Characteristics with Donor, Recovery, and Processing Characteristics (continued)
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Univariate Correlation of Islet Characteristics with Donor, Recovery, and Processing Characteristics (continued)
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Pre Infusion Portal Pressure by Infusion Sequence
348 248 77
1 2 3
0
5
10
15
20
25
30
mm
Hg
Infusion Sequence
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Peak Portal Pressure by Infusion Sequence
328 239 75
(One at infusion 1)Values greater than 40 mmHg are not displayed
1 2 3
0
10
20
30
40
mm
Hg
Infusion Sequence
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Closure Portal Pressure by Infusion Sequence
343 246 76
1 2 3
0
10
20
30
40
mm
Hg
Infusion Sequence
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Change from Pre Infusion to Closure Portal Pressure by Infusion Sequence
340 245 75
(One at infusion 1)Values greater than 20 mmHg are not displayed
1 2 3
-10
-5
0
5
10
15
20
mm
Hg
Infusion Sequence
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Change from Pre Infusion to Peak Portal Pressure by Infusion Sequence
327 237 72
(One at infusion 1)Values greater than 20 mmHg are not displayed
1 2 3
-10
-5
0
5
10
15
20
mm
Hg
Infusion Sequence
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Cell Volume Infused per Infusion by Infusion Year
15 24 49 121 95 91 120 83 46 50
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
Cel
l Vol
ume
(mL)
Infusion Year
This graph represents either settled or packed cell volumes depending on center procedure. Higher volumes typically represent
unpacked cells.
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IEQs Infused per Infusion by Infusion Year
15 24 50 123 106 104 134 93 55 65
(One at 2005)Values greater than 1250000 are not displayed
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
0
250000
500000
750000
1000000
1250000
IEQ
s
Infusion Year
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Chapter 4: Immunosuppression and other Medications
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Immunosuppression Regimen at Time of First Infusion
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Immunosuppression Regimen at Time of First Infusion (continued)
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Biologic Agents Used Peri First Infusion for Induction Therapy
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Biologic Agents Used Peri First Infusion for Induction Therapy
Ant i CD3*Ant i I L2Al oneAnt i I L2+DSGAnt i I L2+TNFBMonoTCDAl one
MonoTCD+Ant i I L2/ TNFBPol yTCD al onePol yTCD+TNFBPol yTCD+AI L2( +/ - TNFB)Unr epor t ed
99- 00
01- 02
03- 04
05- 06
07- 08Year of 1st I nf usi on
1 2 3I nf usi on Sequence
19 13 4
115 62 9
100 86 36
111 88 30
67 41 16
Induction immunosuppression combinations given to allograft recipients, according to infusion sequence (horizontal axis), and transplantation
era (1999-2000, 01-02. etc, perspective axis). Substantial shifts away from Anti-IL2 alone (blue) to other combinations is evident in recent time
periods.
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Immunosuppression Therapy Use at Specified Times Post Last Infusion Allograft Recipients without Reported Graft Failure at the Time of Follow-Up
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Immunosuppression Therapy Use at Specified Times Post Last Infusion Allograft Recipients without Reported Graft Failure at the Time of Follow-Up
(continued)
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Maintenance Immunosuppression Therapy Use Post Initial Infusionby Transplantation Era
Cal ci neur i nI nh+mTORCal ci neur i nI nh+I nosi neI nhCal ci ner i nI nh+mTOR+I nosi neI nhmTOR Al one/ +I nosi neI nh/ +St er oi d
Al l Ot her Combi nat i onsGr af t Fai l ur eNo Dat a
99- 00
01- 02
03- 04
05- 06
07- 08Year of 1st I nf usi on
0 6 12 24 36 48 60Mont hs Post Fi r st I nf usi on
19 19 19 19 19 19 19
115 115 115 115 115 115 113
100 100 100 100 100 91 46
111 111 111 111 75 6
67 50 39 5
Maintenance immunosuppression combinations given to allograft recipients, according to time (months from initial infusion, horizontal axis), and
transplantation era (1999-2000, 01-02. etc, perspective axis). The total number expected at each follow-up time point is accounted for. Complete graft
loss trumps any immunosuppression. Substantial shifts away from the Calcineurin+mTOR combination (yellow) to other combinations is evident from
the start in recent time periods )2007-2008), as well as among those infused in earlier eras (e.g., 2001-2006) and still on immunosuppression at long-term
follow-up (2-5 years).
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Sirolimus Recipient Trough Level (ng/mL) Post Last InfusionAll Allograft Recipients
218 66 225 178 113 71 37
(One at inf 1 day 30 and one at inf 3 day 30)Values greater than 60 ng/mL are not displayed
Inf 1Day 30
Inf 2Day 30
Inf 3Day 30
Month 6Year 1 Year 2 Year 3 Year 4
0.00
10.00
20.00
30.00
40.00
50.00S
irolim
us T
roug
h (n
g/m
L)
Follow-Up
292
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Tacrolimus Recipient Trough Level (ng/mL) Post Last InfusionAll Allograft Recipients
222 69 238 206 142 87 57
Inf 1Day 30
Inf 2Day 30
Inf 3Day 30
Month 6Year 1 Year 2 Year 3 Year 4
0.00
5.00
10.00
15.00
20.00
Tacr
olim
us T
roug
h (n
g/m
L)
Follow-Up
301
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Anti-Hypertensive Medications Pre Infusion and Post Last InfusionAll Allograft Recipients
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Total Number of Anti-Hypertensive Medications Pre Infusion and Post Last Infusion
All Allograft Recipients
Total Number of Medications 4321
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3 Year 4
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Lipid Lowering Medications Pre Infusion and Post Last InfusionAll Allograft Recipients
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Total Number of Lipid Lowering MedicationsPre Infusion and Post Last Infusion
All Allograft Recipients
Total Number of Medications 21
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3 Visit Year 4
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Adjunctive Therapy Used at Time of First InfusionAll Allograft Recipients
VitaminsRosiglitizonePioglitazonePentoxifyllinePantoprazole
Ondansetron HydrochlorideNicotinamide
MetforminIron Supplements
EnoxaparinAspirin
AntiviralsAntifungalsAntibiotics
Percent of Recipients0 10 20 30 40 50 60 70 80 90 100
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Adjunctive Therapy Post Last InfusionAll Allograft Recipients
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Chapter 5: Graft Function
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Insulin Independence, Insulin Dependence, Absence of Fasting C-peptide, or Re-Infusion
Post First InfusionA. Islet Alone Recipients
*Year 3 status regardless of re-infusion
Recipient Status Re-Infused Prior to Follow-UpInsulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptide or Known Graft LossMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Day 30N=347
Day 75N=346
Month 6N=328
Year 1N=318
Year 3*N=257
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Insulin Independence, Insulin Dependence, Absence of Fasting C-peptide, or Re-Infusion
Post First Infusion B. Islet After Kidney Recipients
*Year 3 status regardless of re-infusion
Recipient Status Re-Infused Prior to Follow-UpInsulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptide or Known Graft LossMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Day 30N=65
Day 75N=65
Month 6N=65
Year 1N=61
Year 3*N=47
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Insulin Independence, Insulin Dependence or Absence of Fasting C-peptide
Post Last Infusion A. Islet Alone Recipients
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptide or Known Graft LossMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Month 6N=314
Year 1N=298
Year 2N=266
Year 3N=216
Year 4N=155
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Insulin Independence, Insulin Dependence or Absence of Fasting C-peptide
Post Last InfusionB. Islet After Kidney Recipients
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptide or Known Graft LossMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Month 6N=63
Year 1N=59
Year 2N=49
Year 3N=42
Year 4N=35
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Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptidePost Last Infusion by Total Number of Infusions Received
Islet Alone RecipientsA. Recipients of 1 Infusion
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptide or Known Graft LossMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Month 6N=81
Year 1N=77
Year 2N=63
Year 3N=48
Year 4N=37
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Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptidePost Last Infusion by Total Number of Infusions Received
Islet Alone RecipientsB. Recipients of 2 Infusions
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptide or Known Graft LossMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Month 6N=155
Year 1N=147
Year 2N=133
Year 3N=112
Year 4N=77
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Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptidePost Last Infusion by Total Number of Infusions Received
Islet Alone RecipientsC. Recipients of 3 Infusions
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptide or Known Graft LossMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Month 6N=78
Year 1N=74
Year 2N=70
Year 3N=56
Year 4N=41
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Prevalence of Insulin Independence Post Last InfusionIslet Alone Recipients
Best Case Reported Worst Case
Per
cent
Insu
lin In
depe
nden
t
0
10
20
30
40
50
60
70
Months Post Last Infusion0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48
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Prevalence of Insulin Independence Post Last Infusion By Total Number of Infusions Received
Islet Alone Recipients
Total Number of Infusions Received OneTwo
Three+
Per
cent
Insu
lin In
depe
nden
t
0
10
20
30
40
50
60
70
Months Post Last Infusion0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48
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Achievement of Insulin Independence
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Persistence of Insulin IndependenceAllograft Recipients Achieving Insulin Independence
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Average Daily Insulin (Units) Baseline and Post Last Infusion
A. Islet Alone Recipients
330 279 258 221 171 114
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3 Year 4
0
20
40
60
80
100A
vera
ge D
aily
Insu
lin U
se (U
nits
)
Follow-Up
![Page 88: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/88.jpg)
Average Daily Insulin (Units) Taken By Recipients on Insulin
Baseline and Post Last InfusionB. Islet After Kidney Recipients
62 51 48 38 32 23
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3 Year 4
0
20
40
60
80
100
Ave
rage
Dai
ly In
sulin
Use
(Uni
ts)
Follow-Up
![Page 89: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/89.jpg)
Average Daily Insulin (Units/Kg)Baseline and Post Last Infusion
A. Islet Alone Recipients
326 279 258 221 170 114
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3 Year 4
0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
Ave
rage
Dai
ly In
sulin
Use
(Uni
ts/k
g)
Follow-Up
![Page 90: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/90.jpg)
Average Daily Insulin (Units/Kg)Baseline and Post Last InfusionB. Islet After Kidney Recipients
60 51 48 38 32 23
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3 Year 4
0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
Ave
rage
Dai
ly In
sulin
Use
(Uni
ts/k
g)
Follow-Up
![Page 91: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/91.jpg)
Percent of Baseline InsulinFollow-Up Post Last Infusion
A. Islet Alone Recipients
0%<25%25-49%50-74%>=75%Missing Data
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Month 6N=314
Year 1N=298
Year 2N=266
Year 3N=216
Year 4N=155
![Page 92: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/92.jpg)
Percent of Baseline InsulinFollow-Up Post Last Infusion
B. Islet After Kidney Recipients
0%<25%25-49%50-74%>=75%Missing Data
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Month 6N=63
Year 1N=59
Year 2N=49
Year 3N=42
Year 4N=35
![Page 93: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/93.jpg)
Complete Islet Graft Failure Post Last InfusionA. Islet Alone Recipients
Complete Graft FailureMissing DataGraft Function
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Day 30N=347
Month 6N=314
Year 1N=298
Year 2N=266
Year 3N=216
Year 4N=155
![Page 94: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/94.jpg)
Complete Islet Graft Failure Post Last InfusionB. Islet After Kidney Recipients
Complete Graft FailureMissing DataGraft Function
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Day 30N=65
Month 6N=63
Year 1N=59
Year 2N=49
Year 3N=42
Year 4N=35
![Page 95: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/95.jpg)
Persistence of Graft FunctionAll Allograft Recipients
![Page 96: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/96.jpg)
Outcomes Post First Infusion
![Page 97: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/97.jpg)
Outcomes Post Second Infusion
![Page 98: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/98.jpg)
Outcomes Post Third Infusion
![Page 99: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/99.jpg)
Primary Outcomes Post First Infusion Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients
![Page 100: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/100.jpg)
Primary Outcomes Post First Infusion Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients (continued)
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Primary Outcomes Post First Infusion Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients (continued)
![Page 102: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/102.jpg)
Primary Outcomes Post First Infusion Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients (continued)
![Page 103: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/103.jpg)
Primary Outcomes Post First Infusion Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients (continued)
![Page 104: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/104.jpg)
Primary Outcomes Post First Infusion Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients (continued)
![Page 105: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/105.jpg)
Primary Outcomes Post First Infusion Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients (continued)
![Page 106: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/106.jpg)
Achievement of Insulin Independence Post First Infusion Forest Plot (Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant p < 0.10Factors
Etanercept
Anti-CD3
Cumulative IEQs infused/kg recipient (100s) Cumulative IEQs infused (1000s)
Total volume infused over all infusions (ml)Total IEQs at time of islet count (1000s)
Viability > 87% (0=N 1=Y) Islet Viability (%)
Cold ischemia time (hrs)
Death to pancreas recovery (hrs)
Donor(s) CMV+ / Recipient CMV- (0=N 1=Y) Donor(s)-recipient BMI difference (x10)
Donor(s)-recipient age difference (x10-yrs)
Gradient type
Procurement/infusion teams (0-Unrelated 1-Related)
Donor(s) BMI Donor(s) BSA
Donor(s) weight (10-kg) Donor(s) given steroids (0=N 1=Y)
Donor(s) given vasopressors (0=N 1=Y)
Donor(s) blood type (1=A,B,AB 2=O) Donor race (0=W 1=Non-white)
Baseline fasting glucose (mg/dL) Baseline HbA1c (%)
Baseline number of daily insulin injectionsBaseline BMI
Baseline weight (10-kg) Baseline daily insulin use (Units)
Recipient gender (0=M 1=F) -1
Hazard ratio (95% CI)
0.125 0.25 0.5 1 2 4 8
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Loss of Insulin Independence Post First Infusion Forest Plot (Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant p < 0.10Factors
Monoclonal anti-IL2R + calc inh + (mtor OR inosine) Poly or mono T-cell AB + calc inh + (mtor OR inosine)
Sirolimus
Daclizumab
Anti-Il2
Total volume infused over all infusions (ml)
Total endotoxin infused/kg donor Total endotoxin infused
Total insulin content of islets Total beta cells/kg donor
Stimulation index <2/2-3.5/>=3.5 Stimulation index
Cold ischemia time (hrs)
Genders match (0=N 1=Y)
Culture time (hrs) Cultured >6 hrs (0=N 1=Y)
Processing/infusion center (0-Unrelated 1-Related) Procurement/infusion teams (0-Unrelated 1-Related)
Donor(s) ALT Donor(s) AST
Donor(s) insulin (0=N 1=Y)
Donor(s) given vasopressors (0=N 1=Y) Donor(s) ETOH (0=N 1=Y)
Donor(s) Hispanic (0=N 1=Y)
Baseline C-peptide (ng/mL) Baseline HbA1c (%)
Diabetes Duration (years)
Cohort 1999-2004/05-08 -1
Hazard ratio (95% CI)
0.125 0.25 0.5 1 2 4 8
![Page 108: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/108.jpg)
Complete Islet Failure Post First Infusion Forest Plot (Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant p < 0.10Factors
MonoAntiIL2R+TNFa+CalcInh+mTOR/inosine
Tacrolimus Calcineurin inhibitor
Etanercept TNF blocker
Isletsize (0-small 1-large) IEQ/islet particle ratio
Total beta cells/kg donor
Donor(s)-recipient age difference (x10-yrs) Culture time (hrs)
Cultured >6 hrs (0=N 1=Y)
Processing/infusion ctr (0-Unrelated 1-Related)
Donor(s) insulin (0=N 1=Y)
Donor race (0=W 1=Non-white)
Baseline total positive AABs (0,1,2,3) Baseline insulin AABs (0,1)
Baseline IA-2 AABs (0,1) Baseline GAD 65 AABs (0,1)
Baseline HbA1c (%) Intensive therapy <10/10-25/>=25 yrs
Years intensive therapy
Baseline BMI
Diabetes Duration (years) Recipient age (years)
-1
Hazard ratio (95% CI)
0.125 0.25 0.5 1 2 4 8
![Page 109: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/109.jpg)
Reinfusion Post First Infusion Forest Plot (Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant p < 0.10Factors
Monoclonal anti-IL2R + calc inh + (mtor OR inosine) Poly/mono T-cell AB + TNF-a + CalcInh + mTOR/Inosine
Poly/mono T-cell AB + CalcInh + mTOR/nosine) Prednisone, Methylprednisolone, or other steroid
MMF Inosine: MMF or mycophenolic acid
Sirolimus Sirolimus or Everolimus
Tacrolimus Calcineurin inhibitor
Etanercept Infliximab
TNF blocker Anti-CD3
Daclizumab Anti-Il2
Rabbit thymoglobulin Poly T-cell depleting
IEQ/islet particle ratio Cumulative IEQs infused/kg recipient (100s)
Cumulative IEQs infused (1000s) Total volume infused over all infusions (ml)
Total IEQs at time of islet count (1000s) Endotoxin/kg <0.6/.06-3.0/>=3.0
Total beta cells/kg donorTotal beta cells (1000s)
Viability > 87% (0=N 1=Y) Islet Viability (%)
Death to transplant (hrs) Death to cross-clamp (hrs) Recovery to transplant (hrs)
Death to pancreas recovery (hrs)
Recipient insulin day 0 (0=N 1=Y)
Donor(s)-recipient BMI difference (x10) Donor(s)-recipient age difference (x10-yrs)
Collagenase (1=Liberase alone 2=Other)
Any positive crossmatch (0=N 1=Y)
Donor(s) serum lipase
Donor(s) BMI Donor(s) BSA
Donor(s) weight (10-kg) Donor(s) insulin (0=N 1=Y)
Donor(s) ETOH (0=N 1=Y)
Donor(s) blood type (1=A,B,AB 2=O)
Donor age (x10 yrs)
Baseline HbA1c (%)
Baseline use of insulin pump (0=N 1=Y)
Baseline weight (10-kg) Baseline daily insulin use (Units)
Recipient gender (0=M 1=F) Cohort 1999-2004/05-08
-1
Hazard ratio (95% CI)
0.125 0.25 0.5 1 2 4 8
![Page 110: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/110.jpg)
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
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Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
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Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
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Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
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Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
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Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
![Page 116: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/116.jpg)
Achievement of Insulin Independence Post Last Infusion Forest Plot (Hazard Ratio ± 95% Confidence Interval)
of Factors Univariately Significant p < 0.10Factors
Reexposed to B locus mismatch Number of A/B/DR/DQ locus mismatches
Number of A/B/DR locus mismatches Number of Class I locus mismatches
Number of B locus mismatches Number of A locus mismatches
MonoAntiIL2R + CalcInh + mTOR/Inosine Poly/MonoT-cellAB + TNF-aAnt + CalcInh + mTOR/Inosine
MMF Inosine: MMF or mycophenolic acid
Tacrolimus Calcineurin inhibitor
Daclizumab
Anti-Il2
Rabbit thymoglobulin Poly T-cell depleting
Viability > 87% (0=N 1=Y)
Recovery to transplant (hrs) Time from admission to death (hrs)
Recipient insulin day 0 (0=N 1=Y)
Gradient type
Processing/infusion center (0-Unrelated 1-Related) Procurement/infusion teams (0-Unrelated 1-Related)
Donor(s) BUN Donor(s) creatinine
Donor(s) height (cm)
Donor(s) given steroids (0=N 1=Y)
Donor(s) ETOH (0=N 1=Y)
Donor race (0=W 1=Non-white) Donor(s) Hispanic (0=N 1=Y)
Baseline HbA1c (%)
Hazard ratio (95% CI)
0.125 0.25 0.5 1 2 4 8
![Page 117: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/117.jpg)
Loss of Insulin Independence Post Last Infusion Forest Plot (Hazard Ratio ± 95% Confidence Interval)
of Factors Univariately Significant p < 0.10Factors
MonoAnti-IL2R + CalcInh + mTOR/Inosine
Prednisone, Methylprednisolone, or other steroid MMF
Inosine: MMF or mycophenolic acid Sirolimus
Infliximab
Daclizumab
Anti-Il2
Rabbit thymoglobulin Isletsize (0-small 1-large)
Donor(s)-recipient age difference (x10-yrs)
Processing/infusion center (0-Unrelated 1-Related)
Donor(s) bilirubin
Donor(s) insulin (0=N 1=Y)
Donor(s) given vasopressors (0=N 1=Y)
Donor age (x10 yrs)
Baseline GAD 65 autoantibodies (0,1) Baseline C-peptide (ng/mL)
Baseline use of insulin pump or >=3 insulin inject
Baseline daily insulin use (Units) Diabetes Duration (years)
Hazard ratio (95% CI)
0.125 0.25 0.5 1 2 4 8
![Page 118: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/118.jpg)
Complete Islet Failure Post Last Infusion Forest Plot (Hazard Ratio ± 95% Confidence Interval)
of Factors Univariately Significant p < 0.10Factors
Reexposed to A locus mismatch
MonoAnti-IL2R + TNF-aAnta + CalcInh + mTOR/Inosine
MMF
Tacrolimus Calcineurin inhibitor
Etanercept TNF blocker Daclizumab
Anti-Il2
Horse thymoglobulin
Total beta cells/kg donor Viability > 87% (0=N 1=Y)
Islet Viability (%) Stimulation index
Death to transplant (hrs) Recovery to transplant (hrs)
Donor(s)-recipient age difference (x10-yrs) Culture time (hrs)
Cultured >6 hrs (0=N 1=Y)
Processing/infusion center (0-Unrelated 1-Related) Procurement/infusion teams (0-Unrelated 1-Related)
Donor(s) BMI
Donor race (0=W 1=Non-white)
Total donors Baseline total positive autoantobodies (0,1,2,3)
Baseline IA-2 autoantibodies (0,1) Baseline C-peptide (ng/mL)
Baseline HbA1c (%) Intensive therapy <10/10-25/>=25 yrs
Years prior to first inf using ins pump or >= 3 in
Baseline use of insulin pump (0=N 1=Y)
Diabetes Duration (years) Employment impacted by dx
Recipient age (years)
Hazard ratio (95% CI)
0.125 0.25 0.5 1 2 4 8
![Page 119: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/119.jpg)
C-peptide 0.5 ng/mLA. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
C-peptide < 0.5 ng/mL or Known Graft LossC-peptide >= 0.5 ng/mLMissing data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
Pre Inf 1N=347
Month 6152
Year 1112
![Page 120: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/120.jpg)
C-peptide 0.5 ng/mLA. Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
C-peptide < 0.5 ng/mL or Known Graft LossC-peptide >= 0.5 ng/mLMissing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
Pre Inf 1N=65
Month 624
Year 116
![Page 121: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/121.jpg)
C-peptide 0.5 ng/mLB. Post Last InfusionIslet Alone Recipients
C-peptide < 0.5 ng/mL or Known Graft LossC-peptide >= 0.5 ng/mLMissing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
Pre Inf 1N=347
Month 6314
Year 1298
Year 2266
Year 3216
Year 4155
![Page 122: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/122.jpg)
C-peptide 0.5 ng/mLB. Post Last Infusion
Islet After Kidney Recipients
C-peptide < 0.5 ng/mL or Known Graft LossC-peptide >= 0.5 ng/mLMissing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
Pre Inf 1N=65
Month 663
Year 159
Year 249
Year 342
Year 4N35
![Page 123: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/123.jpg)
C-peptide 0.3 ng/mLC. Post Last Infusion
With or Without Missing Data
![Page 124: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/124.jpg)
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
325 229 78 291 276 239 182 120
(One at pre-inf 2, three at month 6, one at year 1, and one at year 3)Values greater than 6 ng/ml are not displayed or used in boxplot values
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
1
2
3
4
5
6
ng/m
L
Follow-Up
57 46 11 56 53 39 32 22
(One at year 2)Values greater than 6 ng/ml are not displayed or used in boxplot values
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
1
2
3
4
5
6
ng/m
LFollow-Up
![Page 125: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/125.jpg)
Association of Islet Graft Function with Insulin Independence:Percent Insulin Independent by C-peptide Level Post Last Infusion
![Page 126: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/126.jpg)
Basal Plasma C-Peptide (ng/mL) Pre and Post First Infusion
Insulin Independent Recipients
A. Islet Alone Recipients B. Islet After Kidney Recipients
325 14 36 150 154
(One at month 6 and one at year 1)Values greater than 6 ng/mL are not displayed or used in boxplot values
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
1
2
3
4
5
6
ng/m
L
Follow-Up
57 1 6 25 19
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
1
2
3
4
5
6
ng/m
L
Follow-Up
![Page 127: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/127.jpg)
Basal Plasma C-Peptide (ng/mL) Pre and Post First Infusion
Insulin Dependent Recipients
A. Islet Alone Recipients B. Islet After Kidney Recipients
325 266 280 141 135
(One at day 7)Values greater than 6 ng/mL are not displayed or used in boxplot values
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
1
2
3
4
5
6
ng/m
L
Follow-Up
57 40 46 28 30
(One at day 30)Values greater than 6 ng/mL are not displayed or used in boxplot values
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
1
2
3
4
5
6
ng/m
L
Follow-Up
![Page 128: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/128.jpg)
Percent of Insulin Dependent Recipients with Basal C-Peptide 0.5 ng/mLPost Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
Pre Inf 1N=347
Month 6131
Year 1147
Year 2148
Year 3122
Year 496
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
Pre Inf 1N=65
Month 622
Year 130
Year 230
Year 333
Year 423
![Page 129: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/129.jpg)
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
320 242 84 300 281 237 179 116
(Five at pre-inf 1, one at month 6, one at year 1, tw o at year 2, one at year 3 and tw o at year 4)Values greater than 400 mg/dL are not displayed or used in boxplot values
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
100
200
300
400
mg/
dL
Follow-Up
56 48 13 57 54 42 37 23
(Tw o at pre-inf 1, one at year 2 and one at year 4)Values greater than 400 mg/dL are not displayed or used in boxplot values
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
100
200
300
400
mg/
dL
Follow-Up
![Page 130: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/130.jpg)
Fasting Plasma Glucose (mg/dL) Pre and Post First Infusion
Insulin Independent Recipients
A. Islet Alone Recipients B. Islet After Kidney Recipients
56 2 7 24 18
(Tw o at pre-inf 1)Values greater than 400 mg/dL are not displayed or used in boxplot values
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
100
200
300
400
mg/
dLFollow-Up
320 18 38 144 145
(Five at pre-inf 1)Values greater than 400 mg/dL are not displayed or used in boxplot values
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
100
200
300
400
mg/
dL
Follow-Up
![Page 131: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/131.jpg)
Fasting Plasma Glucose (mg/dL) Pre and Post First Infusion
Insulin Dependent Recipients
A. Islet Alone Recipients B. Islet After Kidney Recipients
56 47 47 32 34
(Tw o at pre-inf 1)Values greater than 400 mg/dL are not displayed or used in boxplot values
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
100
200
300
400
mg/
dL
Follow-Up
320 284 285 153 142
(Five at pre-inf 1)Values greater than 400 mg/dL are not displayed or used in boxplot values
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
100
200
300
400
mg/
dL
Follow-Up
![Page 132: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/132.jpg)
Percent of Recipients with Fasting Blood Glucose 126 mg/dLPost Last Infusion by Insulin Status
A. Islet Alone Recipients B. Islet After Kidney Recipients
Insulin Status Independent DependentP
erce
nt o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Infusion 1N=0:56
Month 6N=33:22
Year 1N=23:30
Year 2N=12:29
Year 3N=4:31
Year 4N=3:19
Insulin Status Independent Dependent
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Infusion 1N=0:320
Month 6N=171:126
Year 1N=137:142
Year 2N=90:139
Year 3N=54:119
Year 4N=23:91
![Page 133: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/133.jpg)
Composite Outcome (Hypoglycemia and HbA1C) Post Last InfusionA. Islet Alone Recipients
No severe hypoglycemic episodes and HbA1c < 6.5%No severe hypoglycemic episodes and 6.5% <= HbA1c < 7.0%Severe hypoglycemic episode or HbA1c >= 7.0% with detectable fasting c-peptideSevere hypoglycemic episode or HbA1c >= 7.0% without detectable fasting c-peptideMissing data for recipient with islet graft failureOther missing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
Pre Infusion 1N=347
Day 30347
Month 6314
Year 1298
Year 2266
Year 3216
Year 4155
![Page 134: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/134.jpg)
Composite Outcome (Hypoglycemia and HbA1C) Post Last InfusionB. Islet After Kidney Recipients
No severe hypoglycemic episodes and HbA1c < 6.5%No severe hypoglycemic episodes and 6.5% <= HbA1c < 7.0%Severe hypoglycemic episode or HbA1c >= 7.0% with detectable fasting c-peptideSevere hypoglycemic episode or HbA1c >= 7.0% without detectable fasting c-peptideMissing data for recipient with islet graft failureOther missing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
Pre Infusion 1N=65
Day 3065
Month 663
Year 159
Year 249
Year 342
Year 435
![Page 135: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/135.jpg)
Severe HypoglycemiaA. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
No severe hypoglycemic episodesSevere hypoglycemic episodeMissing data for recipient with islet graft failureOther missing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=347
Month 6N=152
Year 1N=112
![Page 136: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/136.jpg)
Severe HypoglycemiaB. Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
No severe hypoglycemic episodesSevere hypoglycemic episodeMissing data for recipient with islet graft failureOther missing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=65
Month 6N=24
Year 1N=16
![Page 137: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/137.jpg)
Severe HypoglycemiaC. Post Last Infusion Islet Alone Recipients
No severe hypoglycemic episodesSevere hypoglycemic episodeMissing data for recipient with islet graft failureOther missing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=347
Day 30N=347
Month 6N=314
Year 1N=298
Year 2N=266
Year 3N=216
Year 4N=155
![Page 138: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/138.jpg)
Severe HypoglycemiaD. Post Last Infusion
Islet After Kidney Recipients
No severe hypoglycemic episodesSevere hypoglycemic episodeMissing data for recipient with islet graft failureOther missing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=65
Day 30N=65
Month 6N=63
Year 1N=59
Year 2N=49
Year 3N=42
Year 4N=35
![Page 139: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/139.jpg)
Severe HypoglycemiaE. Post Last Infusion
Islet Alone Recipients with Detectable Fasting C-peptide
Severe hypoglycemic episodeMissing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=65
Day 30N=325
Month 6N=278
Year 1N=237
Year 2N=170
Year 3N=114
Year 4N=68
![Page 140: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/140.jpg)
Severe Hypoglycemia
F1. All Islet Alone Recipients with
No Detectable Fasting C-peptide or Known Graft Loss
Post Last Infusion
F2.(Subset of F1): Islet Alone Recipients with
No Detectable Fasting C-peptide or Known Graft Loss and
Known Information on Occurrence of Severe Hypoglycemic Episodes
Post Last Infusion
Severe hypoglycemic episodeMissing dataNo severe hypoglycemic episode
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=260
Day 30N=22
Month 6N=39
Year 1N=54
Year 2N=81
Year 3N=76
Year 4N=67
Severe hypoglycemic episodeNo severe hypoglycemic episode
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=354
Day 30N=20
Month 6N=32
Year 1N=29
Year 2N=38
Year 3N=22
Year 4N=13
![Page 141: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/141.jpg)
Hypoglycemia Status Pre First Infusion and Post Last Infusion
All Allograft Recipients
No hypogl ycemi c epi sodesHavi ng epi sodes and awar ePar t i al awar enessHypogl ycemi a unawar enessMi ssi ng dat a f or r eci pi ent wi t h i sl et gr af t f ai l ur eOt her mi ssi ng dat a
Perc
ent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Pr e I nf 1N=412
Mont h 6N=377
Year 1N=357
Year 2N=315
Year 3N=258
Year 4N=190
![Page 142: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/142.jpg)
HbA1C A. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
HbA1c < 6.5%6.5% <= HbA1c < 7.0%HbA1c >= 7.0%Missing data for recipient with islet graft failureOther missing data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Inf 1N=347
Month 6152
Year 1112
![Page 143: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/143.jpg)
HbA1C A. Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
HbA1c < 6.5%6.5% <= HbA1c < 7.0%HbA1c >= 7.0%Missing data for recipient with islet graft failureOther missing data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Inf 1N=65
Month 624
Year 116
![Page 144: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/144.jpg)
HbA1CB. Post Last InfusionIslet Alone Recipients
HbA1c < 6.5%6.5% <= HbA1c < 7.0%HbA1c >= 7.0%Missing data for recipient with islet graft failureOther missing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
Pre Inf 1N=347
Month 6314
Year 1298
Year 2266
Year 3216
Year 4155
![Page 145: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/145.jpg)
HbA1CB. Post Last Infusion
Islet After Kidney Recipients
HbA1c < 6.5%6.5% <= HbA1c < 7.0%HbA1c >= 7.0%Missing data for recipient with islet graft failureOther missing data
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
Pre Inf 1N=65
Month 663
Year 159
Year 249
Year 342
Year 435
![Page 146: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/146.jpg)
HbA1C (%)Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
329 225 82 291 275 231 180 116
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
59 47 12 55 51 42 35 23
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
![Page 147: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/147.jpg)
HbA1C (%) Pre and Post First InfusionInsulin Independent Recipients
A. Islet Alone Recipients B. Islet After Kidney Recipients
59 4 22 17
Pre Inf 1 Day 30 Month 6 Year 1
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
329 29 138 142
Pre Inf 1 Day 30 Month 6 Year 1
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
![Page 148: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/148.jpg)
HbA1C (%) Pre and Post First InfusionInsulin Dependent Recipients
A. Islet Alone Recipients B. Islet After Kidney Recipients
59 24 30 30
Pre Inf 1 Day 30 Month 6 Year 1
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
329 178 145 138
Pre Inf 1 Day 30 Month 6 Year 1
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
![Page 149: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/149.jpg)
Recipients with HbA1C < 6.5%Percent of Post Last Infusion by Insulin Status
A. Islet Alone Recipients
Insulin Status Independent Dependent
Perc
ent o
f Rec
ipie
nts
0
10
20
30
40
50
60
70
80
90
100
Pre Infusion 1N=0:329
Month 6N=169:120
Year 1N=135:138
Year 2N=88:137
Year 3N=54:119
Year 4N=23:90
![Page 150: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/150.jpg)
Complications of DiabetesPre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Peripheral Neuropathy Autonomic Neuropathy
DisablingSymptomaticAsymptomaticNone
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=383
Month 6N=263
Year 1N=216
Year 2N=147
Year 3N=96
Year 4N=52
DisablingSymptomaticAsymptomaticNone
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=371
Month 6N=266
Year 1N=216
Year 2N=144
Year 3N=96
Year 4N=53
![Page 151: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/151.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Nefropathy Coronary Artery Disease
Stable AllograftESRDMacroalbuminuriaMicroalbuminuriaNone
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=380
Month 6N=280
Year 1N=236
Year 2N=151
Year 3N=93
Year 4N=54
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=386
Month 6N=276
Year 1N=230
Year 2N=154
Year 3N=104
Year 4N=54
![Page 152: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/152.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Stroke Peripheral Vascular Disease
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=373
Month 6N=275
Year 1N=231
Year 2N=152
Year 3N=104
Year 4N=54
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=367
Month 6N=273
Year 1N=226
Year 2N=152
Year 3N=101
Year 4N=54
![Page 153: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/153.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Treated Hypertension Foot Ulcers
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=387
Month 6N=295
Year 1N=248
Year 2N=157
Year 3N=104
Year 4N=56
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=347
Month 6N=275
Year 1N=229
Year 2N=151
Year 3N=104
Year 4N=55
![Page 154: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/154.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Lower Limb Amputation Foot Deformity
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=379
Month 6N=283
Year 1N=237
Year 2N=155
Year 3N=105
Year 4N=58
YesNo
Per
cent
of R
ecip
ient
s0
20
40
60
80
100
Pre Inf 1N=354
Month 6N=278
Year 1N=230
Year 2N=154
Year 3N=105
Year 4N=57
![Page 155: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/155.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Dysesthesia Orthostatic Hypotension
YesNo
Per
cent
of R
ecip
ient
s0
20
40
60
80
100
Pre Inf 1N=316
Month 6N=246
Year 1N=212
Year 2N=133
Year 3N=97
Year 4N=53
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=350
Month 6N=262
Year 1N=219
Year 2N=145
Year 3N=99
Year 4N=51
![Page 156: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/156.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Gastroparesis Constipation
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=342
Month 6N=267
Year 1N=223
Year 2N=140
Year 3N=99
Year 4N=51
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=340
Month 6N=270
Year 1N=228
Year 2N=147
Year 3N=99
Year 4N=51
![Page 157: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/157.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Diabetic Diarrhea Fecal Incontinence
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=345
Month 6N=257
Year 1N=220
Year 2N=145
Year 3N=99
Year 4N=52
YesNo
Per
cent
of R
ecip
ient
s0
20
40
60
80
100
Pre Inf 1N=342
Month 6N=268
Year 1N=228
Year 2N=149
Year 3N=100
Year 4N=53
![Page 158: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/158.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Diabetic Bladder Dysfunction Sexual Dysfunction
YesNo
Per
cent
of R
ecip
ient
s0
20
40
60
80
100
Pre Inf 1N=316
Month 6N=233
Year 1N=200
Year 2N=124
Year 3N=85
Year 4N=44
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=341
Month 6N=268
Year 1N=226
Year 2N=144
Year 3N=99
Year 4N=52
![Page 159: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/159.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Retinopathy Diabetic Macular Edema
SevereModerateMildNone
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=352
Month 6N=238
Year 1N=189
Year 2N=114
Year 3N=83
Year 4N=38
ProliferativeNon ProliferativeNone
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=376
Month 6N=239
Year 1N=190
Year 2N=114
Year 3N=80
Year 4N=43
![Page 160: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/160.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Laser Photocoagulation Surgery for
Proliferative Retinopathy
Laser Photocoagulation Surgery for
Diabetic Macular Edema
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=372
Month 6N=287
Year 1N=241
Year 2N=153
Year 3N=105
Year 4N=55
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=357
Month 6N=287
Year 1N=241
Year 2N=153
Year 3N=105
Year 4N=54
![Page 161: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/161.jpg)
Complications of Diabetes (continued)Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Vtirectomy Other Eye Surgery
YesNo
Per
cent
of R
ecip
ient
s0
20
40
60
80
100
Pre Inf 1N=366
Month 6N=287
Year 1N=241
Year 2N=154
Year 3N=105
Year 4N=54
YesNo
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Pre Inf 1N=379
Month 6N=287
Year 1N=241
Year 2N=153
Year 3N=105
Year 4N=54
![Page 162: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/162.jpg)
Chapter 6: Liver, Kidney, Lipid and PRA Effects
![Page 163: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/163.jpg)
ALT (IU/L) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
57 49 13 52 46 34 27 15
(One at pre-inf 2, one at month 6, and one at year 2)Values greater than 150 IU/L are not displayed or used in boxplot values
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
25
50
75
100
125
150
IU/L
Follow-Up
307 211 70 234 193 128 79 45
(Tw o at pre-inf 2, one at month 6, one at year 1, and one at year 2)Values greater than 150 IU/L are not displayed or used in boxplot values
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
25
50
75
100
125
150
IU/L
Follow-Up
![Page 164: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/164.jpg)
AST (IU/L) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
58 49 12 52 46 34 27 15
(One at month 6, and one at year 2)Values greater than 120 IU/L are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
20
40
60
80
100
120
IU/L
Follow-Up
320 233 77 272 229 148 95 51
(One at pre-inf 1, one at pre-inf 2, one at month 6, one at year 1, and one at year 2)Values greater than 120 IU/L are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
20
40
60
80
100
120
IU/L
Follow-Up
![Page 165: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/165.jpg)
Alkaline Phosphatase (IU/L) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
317 229 75 260 229 144 95 50
(Tw o at pre-inf 2, one at month 6, one at year 1, and one at year 2)Values greater than 350 IU/L are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
300
350
IU/L
Follow-Up
56 49 12 48 46 34 27 15
(Four at pre-inf 1, four at pre-inf 2, tw o at year 1, and one at year 2)Values greater than 350 IU/L are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
300
350
IU/L
Follow-Up
![Page 166: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/166.jpg)
Total Bilirubin (mg/dL) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
57 47 13 45 45 34 26 13
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
mg/
dLFollow-Up
319 221 75 251 214 145 94 48
(One at pre-inf 1 and one at year 1)Values greater than 3.5 mg/dL are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
mg/
dL
Follow-Up
![Page 167: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/167.jpg)
Total Cholesterol (mg/dL) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
56 39 9 48 43 34 28 15
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
300
350
mg/
dL
Follow-Up
327 196 69 248 230 152 98 49
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
300
350
mg/
dL
Follow-Up
![Page 168: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/168.jpg)
HDL (mg/dL) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
49 28 5 35 34 27 24 11
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
mg/
dL
Follow-Up
319 179 59 228 218 139 93 47
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
mg/
dL
Follow-Up
![Page 169: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/169.jpg)
LDL (mg/dL) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
47 28 5 35 34 27 24 11
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
300
mg/
dL
Follow-Up
313 178 57 225 214 138 92 47
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
300
mg/
dL
Follow-Up
![Page 170: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/170.jpg)
Triglycerides (mg/dL) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
55 39 9 48 43 34 27 14
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
300
350
400
450
mg/
dLFollow-Up
327 194 69 246 229 150 98 50
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
300
350
400
450
mg/
dL
Follow-Up
![Page 171: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/171.jpg)
Serum Creatinine (mg/dL) Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
62 48 14 54 49 34 28 16
(Tw o at pre-inf 1, one at month 6 and one at year 2)Values greater than 4.0 mg/dL are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
mg/
dLFollow-Up
338 234 78 280 243 169 104 56
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
mg/
dL
Follow-Up
![Page 172: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/172.jpg)
Percent of Recipients with a 30% Increase in Serum Creatinineat Each Follow-up Time Point
A. Islet Alone Recipients B. Islet After Kidney Recipients
>=30% Increase In Serum Creatinine<30% Increase In Serum Creatinine
Per
cent
of R
ecip
ient
s0
20
40
60
80
100
Month 6N=52
Year 1N=47
Year 2N=34
Year 3N=27
Year 4N=15
>=30% Increase In Serum Creatinine<30% Increase In Serum Creatinine
Per
cent
of R
ecip
ient
s
0
20
40
60
80
100
Month 6N=277
Year 1N=240
Year 2N=167
Year 3N=103
Year 4N=55
![Page 173: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/173.jpg)
Cockgroft-Gault Calculated Creatinine Clearance (mL/min/1.73m2)Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
42 18 5 22 27 19 15 10
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
mL/
min
/1.7
3m2
Follow-Up
271 114 35 146 146 66 39 19
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
50
100
150
200
250
mL/
min
/1.7
3m2
Follow-Up
![Page 174: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/174.jpg)
“Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated GFR (mL/min/1.73m2)Pre Infusion and Post Last Infusion
A. Islet Alone Recipients B. Islet After Kidney Recipients
60 47 14 53 48 34 28 16
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
30
60
90
120
150
180
ml/m
in/1
.73
m2
Follow-Up
338 234 78 280 243 169 104 56
(One at pre-inf 1 and one at pre-inf 3)Values greater than 180 ml/min/1.73 m2 are not displayed or used in boxplot values
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
30
60
90
120
150
180
ml/m
in/1
.73
m2
Follow-Up
![Page 175: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/175.jpg)
Class I PRA (%)Pre Infusion and Post Last Infusion
Islet Alone Recipients
303 206 73 200 174 135 98 63
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3 Year 4
0
10
20
30
40
50
60
70
80
90
100
%
Follow-Up
![Page 176: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/176.jpg)
% Change in Class I PRA from Pre First InfusionPre Subsequent Infusion and Post Last Infusion
Islet Alone Recipients
203 71 199 173 134 96 63
(One at pre-inf 3 and one at year 1)Values less than -25 are not displayed
Pre Inf 2 Month 6 Year 2 Year 4
-25
0
25
50
75
100
Cha
nge
from
Pre
Infu
sion
1
Follow-Up
![Page 177: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/177.jpg)
Class I PRA Post Last InfusionIslet Alone Recipients with Complete Graft Loss
11 15 26 18 9
Month 6 Year 1 Year 2 Year 3 Year 4
0
10
20
30
40
50
60
70
80
90
100
%
Follow-Up
![Page 178: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/178.jpg)
Class I PRA Post Last InfusionIslet Alone Recipients without Complete Graft Loss
189 159 109 80 54
Month 6 Year 1 Year 2 Year 3 Year 4
0
10
20
30
40
50
60
70
80
90
100
%
Follow-Up
![Page 179: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/179.jpg)
Class I PRA Post Last InfusionNon-Immunosupressed Islet Alone Recipients
4 7 12 7 3
Month 6 Year 1 Year 2 Year 3 Year 4
0
10
20
30
40
50
60
70
80
90
100
%
Follow-Up
![Page 180: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/180.jpg)
Class I PRA Post Last InfusionImmunosupressed Islet Alone Recipients
191 164 119 87 57
Month 6 Year 1 Year 2 Year 3 Year 4
0
10
20
30
40
50
60
70
80
90
100
%
Follow-Up
![Page 181: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/181.jpg)
Chapter 7: Adverse Events
![Page 182: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/182.jpg)
Percent of Recipients with an Adverse Event (AE) or Serious Adverse Event (SAE)in Year 1 Post First Infusion
![Page 183: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/183.jpg)
Total Number of Adverse Events and Serious Adverse Eventsin Year 1 Post First Infusion
![Page 184: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/184.jpg)
IA: Incidence of Post-Transplant Adverse Events Related to Infusion Procedure
![Page 185: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/185.jpg)
IAK: Incidence of Post-Transplant Adverse Events Related to Infusion Procedure
![Page 186: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/186.jpg)
IA: Incidence of Post-Transplant Adverse Events Related to Immunosupression Therapy Follow-up Based on Completed Scheduled Visits
![Page 187: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/187.jpg)
IAK: Incidence of Post-Transplant Adverse Events Related to Immunosupression Therapy Follow-up based on completed scheduled visits
![Page 188: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/188.jpg)
Percent of Recipients with a Serious Adverse Eventin Year 1 Post First Infusion by Year of First Infusion
All Allograft Recipients
Any SAESAE related to either the infusion procedure or immunosuppressionSAE related to the infusion procedureSAE related to immunosuppression
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
Year of First Infusion1999-2000N=19
2001-2002N=115
2003-2004N=100
2005-2006N=111
2007-2008N=67
![Page 189: CITR Annual Report Exhibits](https://reader035.vdocuments.us/reader035/viewer/2022062218/56815b85550346895dc9874c/html5/thumbnails/189.jpg)
Serious Adverse Event Criteria by Relatedness to Islet Infusion or Immunosuppression
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Outcome of Serious Adverse Events by Relatedness to Islet Infusion or Immunosuppression
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Serious Adverse Events MedDRA System/Organ Classby Relatedness to Islet Infusion or Immunosuppression
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Serious Adverse Events MedDRA System/Organ Classby Relatedness to Islet Infusion or Immunosuppression (continued)
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Most Common Serious Adverse EventsMedDRA Preferred Term
Islet Alone Recipients
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Most Common Serious Adverse Events MedDRA Preferred Term
Islet After Kidney Recipients
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Most Common Serious Adverse Events ReportedWithin One Year of Any Infusion
MedDRA Preferred Term All Allograft Recipients
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Most Common Serious Adverse Events ReportedMore than One Year after Any Infusion
MedDRA Preferred Term All Allograft Recipients
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Listing of Reported NeoplasmsAll Allograft Recipients
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Listing of Reported Neoplasms (continued)All Allograft Recipients
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Listing of Reported Neoplasms (continued)All Allograft Recipients
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Listing of Reported Hemorrhages and Portal Vein ThrombosesAll Allograft Recipients
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Listing of Reported Hemorrhages and Portal Vein Thromboses (continued)All Allograft Recipients
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Listing of Reported Hemorrhages and Portal Vein Thromboses (continued)All Allograft Recipients
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Listing of Reported Hemorrhages and Portal Vein Thromboses (continued)All Allograft Recipients
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Number of Days Hospitalized at Infusion (from Admission to Discharge)by Infusion SequenceIslet Alone Recipients
330 233 75
(Three at infusion 1 and one at infusion 3)Values greater than 20 days are not displayed
1 2 3
0
5
10
15
20
Num
ber o
f Day
s
Infusion Sequence
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Number of Days Hospitalized at Infusion (from Admission to Discharge)by Infusion Sequence
Islet After Kidney Recipients
62 47 13
(Three at infusion 1 and one at infusion 3)Values greater than 20 days are not displayed
1 2 3
0
5
10
15
20
Num
ber o
f Day
s
Infusion Sequence
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Hospitalization Experienced Post Last Infusion by Total Number of Infusions ReceivedIslet Alone Recipients
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Hospitalization Experienced Post Last Infusion by Total Number of Infusions ReceivedIslet After Kidney Recipients
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Chapter 8: Registry Data Quality Review
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Expected and Submitted Forms by Infusion Sequence
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Expected and Submitted Follow-Up Forms Post Last infusionAll Allograft Recipients
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Extent of Follow-Up Post Last InfusionAll Allograft Recipients
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Appendices
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CITR Coordinating Center(July 2008 – July 2009)
PI: Franca Benedicty Barton
Co-PI: Donald Stablein
Yamini Babu
Ruth Danoff
Jodi DeStefano
Andrew Heitman
Krista Huang
Steve Wease
Tina Winters
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Islet Transplant Centers
Baylor College of Medicine/
The Methodist Hospital
Houston, Texas, USA
PI: John A. Goss
Baylor Regional Transplant Institute
Dallas, Texas, USA
PI: Marlon Levy
Benaroya Research Institute
Seattle, Washington, USA
PI: Carla Greenbaum
Carolinas Medical Center
Charlotte, North Carolina, USA
PI: Paul Gores
Center for Islet Transplantation at Harvard
Medical School
Boston, Massachusetts, USA
PI: Enrico Cagliero
Columbia University
New York, New York, USA
PI: Mark A. Hardy
Emory Transplant Center
Atlanta, Georgia, USA
PI: Mark Rigby
GenevaGRAGIL Network
Geneva, Switzerland
PI: Thierry Berney
Lille University Hospital
Lille Cedex, France
PI: Francois Pattou
Mayo Clinic
Rochester, Minnesota, USA
PI: Yogish Kudva
NIH Clinical Transplant Center
Bethesda, Maryland, USA
PI: David Harlan
Northwestern University
Chicago, Illinois, USA
PI: Dixon Kaufman
San Raffaele Institute
Milan, Italy
PI: Antonio Secchi
Scripps Health
La Jolla, California, USA
PI: Christopher Marsh
Southern California Islet Consortium (SCIC)
Duarte, California, USA
PI: Fouad Kandeel
St. Vincent’s Institute
Fitzroy, Victoria, Australia
PI: Tom Kay
Swedish Medical Center
Seattle, Washington, USA
PI: William Marks
Toronto General Hospital
Toronto, Ontario, CANADA
PI: Mark Cattral
The University of Tennessee, Memphis
Memphis, Tennessee, USA
PI: A. Osama Gaber
UMass Memorial Hospital
Worcester, Massachusetts, USA
PI: Aldo Rossini
University of Alabama
Birmingham, Alabama, USA
PI: Juan Luis Contreras
University of Alberta
Edmonton, Alberta, CANADA
PI: A. M. James Shapiro
Co-PI: Peter Senior
Parastoo Dinyari
University of California,
San Francisco
San Francisco, California, USA
PI: Peter Stock
Co-PI: Andrew Posselt
University of Chicago
Chicago, Illinois, USA
PI: Marc Garfinkel
University of Colorado Health Sciences
Center
Auora, Colorado, USA
PI: Alexander Wiseman
University of Illinois, Chicago
Chicago, Illinois, USA
PI: Jose Oberholzer
Co-PI: Enrico Benedetti
Co-PI: James Bui
Co-PI: Charles Owens
University of Miami
Miami, Florida, USA
PI: Rodolfo Alejandro
Co-PI: Camillo Ricordi
University of Minnesota
Minneapolis, Minnesota, USA
PI: Bernhard J. Hering
University of Nebraska
Omaha, Nebraska, USA
PI: R. Brian Stevens
University of Pennsylvania
Philadelphia, Pennsylvania, USA
PI: Ali Naji
University of Virginia
Charlottesville, Virginia, USA
PI: Kenneth Brayman
University of Wisconsin
Madison, Wisconsin, USA
PI: Jon Odorico
Virginia Commonwealth University
Richmond, Virginia, USA
PI: Adrian Cotterell
University of Pennsylvania
Washington University,
St. Louis
St. Louis, Missouri, USA
PI: Niraj Desai
Westmead Hospital
Wentworthville, NSW, Australia
PI: Philip Oconnell
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CITR Committees
Scientific Advisory Committee (SAC)
Compliance Committee (2008)
Data Elements Committee (2008)
Publications/Presentations Committee (2008)
Transplant Coordinators’/Data Managers’ Committee (2008)
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CITR Scientific Advisory Committee (SAC)Chair: Bernhard J. Hering
Michael Appel
Franca Benedicty Barton
Michael Cecka
Philip E. Cryer
Olle Korsgren
Maureen McBride
Jerry P. Palmer
Camillo Ricordi
Gordon Weir
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CITR Compliance Committee (2008)
Chair: Fouad Kandeel
Michael Appel
Parastoo Dinyari
Albert Hwa
Carol Kramer
Joan Martellotto
Violetta Raverdi
Marti Sears
Elyse Stuart
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CITR Data Elements Committee (2008)
Chair: Marti Sears
David Baidal
Enrico Cagliero
Marc Garfinkel
Fouad Kandeel
Dixon Kaufman
Robert Ketchum
Francois Pattou
David Sutherland
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CITR Publications/Presentations Committee (2008)
Chair: Rodolfo Alejandro
Michael Appel
Nancy Bridges
Shari Messinger Cayetano
Brian Flanagan
Elizabeth Holbrook
Robert Ketchum
Bashoo Naziruddin
Craig Smith
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CITR Transplant Coordinators’/Data Managers’ Committee (2008)
Chair: Parastoo Dinyari
Jarrett Anderson
David Baidal
LeAnn Batterson
Meyer Belzer
Elsa Boely
Jane Fasbender
Courtney Garbee
Susan George
Debbie Grice
Darrell Grimes
Jeannette Hacker
Celia Hartigan
Elizabeth Holbrook
Nancy Radke
Violeta Raverdy
Marilyn Reeve
Kristi Schneider
Marti Sears
Jill Sheedy
KD Shiang
Elyse Stuart
Pat Swanson
Heather Turgeon
Patricia Wilson
Dona Winborne
Piotr Witkowski
Robin Jevne
Jenny Joseph
Debra Kemp
Mark Lockwood
Eileen Markmann
Joan Martellotto
Marli McCulloch-Olson
Joan McElroy
Melissa McGraw
Suzanne Miller
Bashoo Naziruddin
Lori Otken
Maral Palanjian
Jamen Parkey
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CITR AllograftsRecipients with C-Peptide ≥ 0.3 Pre-Infusion