Rush was one of 10 premier cardiac centers across the country that participated in the 53-patient, double-blind, placebo-controlled trial. Among other findings, patients receiving Provacel were 75 percent less likely to experience an arrhythmic adverse event compared to those receiving placebo (9 % vs. 37%, p=0.025) and significantly more patients who received Provacel experienced improvement in their overall condition at six months as compared to those receiving placebo (42% vs. 11%, p=0.027).
Provacel is a preparation of adult stem cells pre-formulated for intravenous delivery by the drug's manufacture, Osiris Therapeutics. Patients were administered an infusion of either Provacel or placebo within 10 days of having a heart attack and are being followed for 2 years. To prevent bias, neither the patient nor the physician knows who received the stem cell treatment and who received placebo.
Rush principal investigator cardiologist Dr. Gary Schaer, head of the Rush Cardiac Catheterization Laboratory, says one reason the study results are so promising is that these stem cells can be used without tissue typing and do not trigger an immune response, and are available for every patient.
The mesenchymal stem cells (MSC) are found in the adult bone marrow and have the potential to develop into mature heart cells and new blood vessels. The MSC cells are derived from normal, healthy adult volunteer bone marrow donors and are not derived from a fetus, embryo or animal. Because they are in an early stage of developm
Source:Rush University Medical Center