Intracoronary ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration - ALLSTAR

Contribution To Literature:

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


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)


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.


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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