intracoronary autologous bone-marrow cell transfer after myocardial infarction: a double-blind,...

Intracoronary Autologous Bone-Marrow Cell Transfer Intracoronary Autologous Bone-Marrow Cell Transfer after Myocardial Infarction: A Double-Blind, after Myocardial Infarction: A Double-Blind,

Randomized, and Placebo-Controlled Clinical TrialRandomized, and Placebo-Controlled Clinical Trial

Intracoronary Autologous Bone-Marrow Cell Transfer Intracoronary Autologous Bone-Marrow Cell Transfer after Myocardial Infarction: A Double-Blind, after Myocardial Infarction: A Double-Blind,

Randomized, and Placebo-Controlled Clinical TrialRandomized, and Placebo-Controlled Clinical Trial

Presented atPresented atAmerican College of CardiologyAmerican College of Cardiology

Scientific Sessions 2005Scientific Sessions 2005

Presented by Dr. Stefan JanssensPresented by Dr. Stefan Janssens

Intracoronary Autologous Bone-Marrow Cell Transfer after Myocardial Infarction

www. Clinical trial results.org

Endpoints (mean follow-up 4 months): Global LVEF, LV mass index and infarct size

Endpoints (mean follow-up 4 months): Global LVEF, LV mass index and infarct size



Presented at ACC Scientific Sessions 2005Presented at ACC Scientific Sessions 2005

66 acute MI† patients; time after symptom onset > 2 hours; successful reperfusion post-PCI; documented LV dysfunction

Placebo controlled. Randomized. Blinded. Mean age 56 years. 14% female.

66 acute MI† patients; time after symptom onset > 2 hours; successful reperfusion post-PCI; documented LV dysfunction

Placebo controlled. Randomized. Blinded. Mean age 56 years. 14% female.

Intracoronary autologous bone-marrow cell transfer**

n=32

Intracoronary autologous bone-marrow cell transfer**

n=32

† defined as cumulative ST segment elevation ≥ 6 mm

** bone marrow aspiration was performed and transferred to an open infarct-related artery. The transfer was performed intracoronary using over-the-wire balloon catheter during 3 coronary occlusions. Patients were monitored in-hospital for 7 days and underwent follow-up through 4 months. PET and MRI were performed at the initial hospitalization and at 4 month follow-up.

Placebo

n=34

Placebo

n=34

24 hours later

www. Clinical trial results.org Presented at ACC Scientific Sessions 2005Presented at ACC Scientific Sessions 2005

Improvement in Global LV Ejection Fraction Over 4 Months

2.1%

3.9%

0%

1%1%

2%2%

3%3%

4%4%

5%

Bone Marrow Group Placebo

2.1%

3.9%

0%

1%1%

2%2%

3%3%

4%4%

5%

Bone Marrow Group Placebo



• Bone marrow cell harvest volume Bone marrow cell harvest volume averaged 130 mL, with 304 million averaged 130 mL, with 304 million total nucleated cells and 172 total nucleated cells and 172 mononuclear cells mononuclear cells

• The infarct artery was in the left The infarct artery was in the left coronary in 62% of patients and the coronary in 62% of patients and the right coronary in 37%. right coronary in 37%.

• Post-PCI TIMI flow grade 3 was Post-PCI TIMI flow grade 3 was present in 91% of patients. All but present in 91% of patients. All but one patient received aspirin, and one patient received aspirin, and glycoprotein IIb/IIIa inhibitors were glycoprotein IIb/IIIa inhibitors were used in 78% of the bone marrow used in 78% of the bone marrow group and 64% of the placebo groupgroup and 64% of the placebo group

• Global LVEF increased by 2.1% in the Global LVEF increased by 2.1% in the bone marrow group and 3.9% in the bone marrow group and 3.9% in the placebo groupplacebo group

www. Clinical trial results.org Presented at ACC Scientific Sessions 2005Presented at ACC Scientific Sessions 2005

• There was no difference in change in systolic wall motion in either region• End diastolic wall thickness reduction was larger in the bone marrow group compared with

placebo in both the infarct region and the remote area• There were no differences in the PET perfusion indices or metabolic indices in the infarct region

or in the border zone



0.6 0.6

-1.7

-0.9

1.1 1.1

-1.2

-0.4

-2

-1.5

-1

-0.5

0

0.5

1

1.5

mm

0.6 0.6

-1.7

-0.9

1.1 1.1

-1.2

-0.4

-2

-1.5

-1

-0.5

0

0.5

1

1.5

mm

Infarct Regionp=0.49

Border Zonep=0.94

Infarct Regionp=0.04

Remote Areap=0.05

Systolic Wall Motionfrom baseline to 4 months

End Diastolic Wall Thickness Reductionfrom baseline to 4 months

BMC Placebo BMC Placebo

BMC Placebo BMC Placebo


• At 4 months, LV mass index (p=0.018) and infarct size (p=0.036) At 4 months, LV mass index (p=0.018) and infarct size (p=0.036) were lower in the bone marrow group compared with the placebo were lower in the bone marrow group compared with the placebo group group

• Similar results were observed in infarct size in the subgroup of Similar results were observed in infarct size in the subgroup of patients who underwent PCI within 6 hours and in patients with patients who underwent PCI within 6 hours and in patients with infarct size > 20% of LV mass indexinfarct size > 20% of LV mass index

• There was no difference in adverse events during admission or There was no difference in adverse events during admission or at 4 month-follow-up, with atrial tachycardia on Holter in 19% of at 4 month-follow-up, with atrial tachycardia on Holter in 19% of the bone marrow group and 15% of the placebo groupthe bone marrow group and 15% of the placebo group




Other Principle Findings:


• Among patients with recent reperfusion therapy following myocardial infarction, treatment with intracoronary autologous bone-marrow cell transfer was associated with reductions in infarct size compared with placebo but was not associated with changes in left ventricular systolic functional recovery.

• Bone marrow transfer was not associated with an increase in myocardial blood flow or oxidative metabolism on PET scan.

• While earlier studies have evaluated autologous bone-marrow cell transfer post-MI, the present study is the first to do so in a double-blind placebo controlled manner. Given the safety profile and the potential benefit in infarct size, larger randomized trials of autologous bone-marrow cell transfer are warranted.

• Among patients with recent reperfusion therapy following myocardial infarction, treatment with intracoronary autologous bone-marrow cell transfer was associated with reductions in infarct size compared with placebo but was not associated with changes in left ventricular systolic functional recovery.

• Bone marrow transfer was not associated with an increase in myocardial blood flow or oxidative metabolism on PET scan.

• While earlier studies have evaluated autologous bone-marrow cell transfer post-MI, the present study is the first to do so in a double-blind placebo controlled manner. Given the safety profile and the potential benefit in infarct size, larger randomized trials of autologous bone-marrow cell transfer are warranted.




intracoronary autologous bone-marrow cell transfer after myocardial infarction: a double-blind,...

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