Early Intracoronary Autologous Bone Marrow Cell Infusion in Acute Myocardial Infarction - REGENERATE-AMI

Sep 30, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
UK Stem Cells Foundation, Heart Cells Foundation, and Barts and London Charity.
Date Published:
09/24/2015
Original Posted Date:
09/30/2015
References

Description:

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.

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Placebo

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).

Inclusion criteria:

  • 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%

Principal Findings:

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).

Interpretation:

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.

References:

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].

Keywords: Acute Coronary Syndrome, Anterior Wall Myocardial Infarction, Bone Marrow Cells, Bone Marrow Transplantation, Heart Failure, Myocardial Infarction, Myocardium, Percutaneous Coronary Intervention, Secondary Prevention, Stem Cells, Stroke Volume, Ventricular Function, Left


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