Osiris Announces Findings From Trial of Stem Cells to Treat Heart Disease

Osiris Therapeutics has announced positive six-month results from a Phase I clinical trial evaluating Provacel, an adult mesenchymal stem cell therapy for the treatment of heart disease.

In a 53-patient, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of the intravenous administration of Provacel, heart attack patients receiving the therapy had significantly lower rates of adverse events, such as cardiac arrhythmias, as well as significant improvements in heart and lung function and overall condition. The data was presented at the recent American College of Cardiology meeting.

"We were confident in the safety profile given our previous experience using the intravenous form of these stem cells to treat other diseases in later-stage clinical trials. However, the magnitude of the across-the-board improvement was surprising," C. Randal Mills, president and CEO of Osiris, said. "Based on these encouraging results, we have started working on the design of the next stage of clinical trials."

Patients in the Provacel group were four times less likely to experience an arrhythmic event compared with those receiving placebo. In addition, fewer patients experienced clinically significant premature ventricular contractions after receiving Provacel as compared with placebo across all time points.

Administration of Provacel was found to be well tolerated at all dose levels. There were no patient deaths, and no toxicity was observed with the administration of Provacel. There were fewer adverse events in patients receiving Provacel as compared with placebo.