Early Intracoronary Autologous Bone Marrow Cell Infusion in Acute Myocardial Infarction - REGENERATE-AMI
The goal of the trial was to evaluate intracoronary delivery of autologous bone marrow-derived stem cells compared with placebo within 24 hours of primary percutaneous coronary intervention (PCI).
Contribution to the Literature: The REGENERATE-AMI trial failed to show that intracoronary delivery of autologous bone marrow-derived stem cells improved ejection fraction at 1 year.
Subjects who underwent primary PCI within the last 24 hours were randomized to intracoronary delivery of autologous bone marrow-derived stem cells (n = 55) versus intracoronary delivery of placebo (n = 45).
- Subjects who underwent primary PCI for anterior myocardial infarction within the last 24 hours
- Total number of enrollees: 100
- Duration of follow-up: 1 year
- Mean patient age: 57 years
- Percentage female: 9%
- Percentage diabetics: 9%
The primary outcome, change in ejection fraction at 1 year for stem cells compared with placebo, was 2.2% (p = 0.10).
The secondary outcome was myocardial salvage index for stem cells vs. placebo: 0.1% (p = 0.048).
Among individuals treated with primary PCI for anterior myocardial infarction, intracoronary delivery of autologous bone marrow-derived stem cells failed to improve left ventricular ejection fraction at 1 year. This trial was unique in that it employed rapid delivery of stem cells, whereas most other trials have administered stem cells 1-7 days after myocardial infarction. To date, autologous stem cells have not been able to demonstrate a clinically significant improvement in left ventricular function.
Choudry F, Hamshere S, Saunders N, et al. A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trial. Eur Heart J 2015;Sep 24:[Epub ahead of print].
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