Promising phase 1 trial results on their safety, efficacy in post-MI heart failure
MONDAY, Nov. 14 (HealthDay News) -- Cardiac stem cell (CSC) infusion improves left ventricular (LV) function and reduces infarct size in a phase I trial in patients with post-myocardial infarction (MI) heart failure, according to a study published online Nov. 14 in The Lancet to coincide with presentation at the American Heart Association's Scientific Sessions 2011, held from Nov. 12 to 16 in Orlando, Fla.
Roberto Bolli, M.D., from the University of Louisville in Kentucky, and colleagues investigated the safety and efficacy of treating 16 post-MI heart failure participants with CSCs, compared to seven untreated patients, in a two-stage trial. In stage A, participants with post-MI LV dysfunction (ejection fraction [EF], ≤40 percent) prior to coronary artery bypass grafting (CABG) were consecutively assigned to the treatment versus control groups. In stage B, participants were randomly assigned to the treatment versus to control groups. The trial was ongoing at the time of reporting.
The investigators found no CSC-related adverse effects. The LVEF in 14 patients, who were analyzed from the treatment group, increased from 30.3 to 38.5 percent before and four months post-infusion, respectively; but did not change significantly in control patients at four versus eight months post-CABG. Eight treated patients showed a more pronounced effect at one year, with an LVEF increase of 12.3 EF units from baseline. An average infarct size of 32.6 g was significantly reduced by 7.8 and 9.8 g at four months and one year, respectively, in seven treated patients who underwent cardiac magnetic resonance imaging.
"The present results provide a strong rationale for further studies of CSC treatment in patients with severe heart failure secondary to ischemic cardiomyopathy," the authors write.
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