Phase II results positive for Prochymal (Osiris Therapeutics)following Myocardial Infarction

A Phase II, multi-center, randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of Prochymal (ex-vivo cultured adult human mesenchymal stem cells) intravenous infusion from Osiris Therapeutics, following acute myocardial infarction. A total of 220 patients were randomized (1:1) at 33 centers in the United States and Canada and received a single intravenous infusion of Prochymal or placebo within 7 days following first acute myocardial infarction. In addition to screening and baseline visits prior to the infusion, initially follow-up evaluations were scheduled to be conducted through 2 years. Cardiac MRI assessments were conducted for six months following infarct to evaluate cardiac remodeling. Patients receiving Prochymal had significantly less cardiac hypertrophy, as measured by cardiac MRI, compared to patients receiving placebo (p<0.05).patients treated with prochymal also experienced significantly less stress-induced ventricular arrhythmia p><0.05). cardiac hypertrophy and ventricular arrhythmia are indicators of pathological remodeling following heart injury and provide insight into the mechanism by which mesenchymal stem cells attenuate heart injury following a myocardial infarction. the mechanistic data is complemented by clinical data showing treatment with prochymal resulted in a statistically significant reduction in heart failure. in the study seven patients who were treated with placebo have progressed to heart failure requiring treatment with intravenous diuretics compared to none of the prochymal patients p="0.01)." furthermore patients receiving placebo tended to require re-hospitalization for cardiac issues sooner than the patients receiving prochymal median 27.5 days vs. 85.5 days.the trial also demonstrated that treatment with prochymal was safe. the trial continues.>