Intracoronary ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration - ALLSTAR

Nov 15, 2017
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Presenter/Author:
Timothy D. Henry, MD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Capricor; National Institutes of Health/National Heart, Lung, and Blood Institute; and California Institute for Regenerative Medicine.
Date Presented:
11/15/2017
Date Updated:
11/15/2017
Original Posted Date:
11/15/2017
References

Contribution To Literature:

The ALLSTAR trial failed to show reduction in infarct size from intracoronary injection of stem cells after myocardial infarction.

Description:

The goal of the trial was to evaluate treatment with intracoronary allogeneic stem cells compared with placebo among patients with prior myocardial infarction.


Study Design

  • Randomized
  • Parallel
  • Placebo
  • Blinded

Patients with prior myocardial infarction were randomized to intracoronary allogeneic cardiosphere-derived stem cells (n = 90) versus placebo (n = 44).

  • Total number of enrollees: 142
  • Duration of follow-up: 12 months
  • Mean patient age: 55 years
  • Percentage female: 16%
  • Percentage with diabetes: 26%
  • Mean left ventricular ejection fraction (LVEF): 40%

Inclusion criteria:

  • ≥18 years
  • Prior myocardial infarction in the last 12 months
  • Successful percutaneous coronary intervention  of the infarct-related artery
  • LVEF ≤45%
  • LV infarct size ≥15% of LV mass
  • No further revascularization needed

Exclusion criteria:

  • Prior coronary artery bypass grafting
  • Acute coronary syndrome within prior 4 weeks
  • Previous stem cell therapy
  • Prior implantable cardioverter-defibrillator or pacemaker that is not magnetic resonance imaging compatible
  • Estimated glomerular filtration rate <30 cc/min
  • Current alcohol or drug abuse

Principal Findings:

The primary outcome, percentage change from baseline in infarct size, was similar between groups at 6 months (p = 0.63) and 12 months (p = 0.39).

Secondary outcomes:

  • LV volumes: Similar between groups (p = not significant)
  • Major adverse cardiac events: 7.8% for stem cell group vs. 11.4% for placebo group (p = 0.49)

Interpretation:

Among patients with prior myocardial infarction, intracoronary injection of allogeneic cardiosphere-derived stem cells was not effective. Intracoronary stem cells did not reduce infarct size or improve LV volumes. Clinical events were similar between the groups.

References:

Presented by Dr. Timothy D. Henry at the American Heart Association Annual Scientific Sessions (AHA 2017), Anaheim, CA, November 15, 2017.

Keywords: Acute Coronary Syndrome, AHA17, AHA Annual Scientific Sessions, Heart Failure, Myocardial Infarction, Percutaneous Coronary Intervention, Primary Prevention, Regeneration, Stem Cells, Treatment Outcome


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