ALLSTAR: No Difference in Cell Therapy vs. Placebo in Scar Tissue Reduction
The was no difference between the cell-based therapy CAP-1002 and placebo in reducing the amount of scar tissue in patients with myocardial infarction (MI), according to a preliminary analysis of six-month results of the ALLSTAR trial presented Nov. 15 at AHA 2017 in Anaheim, CA.
Timothy D. Henry, MD, FACC, et al., looked at 142 patients with MI who were randomized to receive a single dose of CAP-1002 (25 million allogeneic cardiosphere-derived cells) or placebo. Patients were treated between 30 days and 12 months following MI.
Results showed that "no primary safety endpoint events occurred" and the primary endpoint of a percent change in infarct size was similar between the two groups based on MRI scan.
The researchers explain that "there was evidence of treatment effect according to several pre-defined secondary efficacy analyses." Further, "there was a statistically significant reduction in end diastolic volume in the treated group as compared to the control," as well as "a strong trend, approaching but not reaching significance, towards reduction of end systolic volume in the treated group."
They conclude that moving forward, the influence of matched vs. unmatched cells should be investigated.
Keywords: AHA17, AHA Annual Scientific Sessions, Double-Blind Method, Heart, Stem Cells, Wound Healing
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