Osiris Stem Cells Safe for Heart Injury

The company's lead product is Prochymal, an intravenous infusion containing MSCs being developed for graft-vs.-host disease and Crohn's disease in phase III studies. Another Osiris stem cell drug in its pipeline, Chrondrogen, recently failed a study in patients with damaged knee cartilage.

Provacel is being developed for heart-related diseases through a partnership between Osiris and Boston Scientific(BSX Quote). Sunday's presentation was the first study of Provacel conducted in patients.

The phase I study enrolled 53 patients hospitalized with their first heart attack. Thirty-four patients were randomized to receive an intravenous infusion of Provacel, split between three different doses. The remaining 19 patients received a sham infusion. Patients were followed for six months after treatment.

The hypothesis behind Provacel is that adult stem cells can migrate to the injured areas of the heart and regenerate into healthy cardiac tissue, reversing the damage done by heart disease.

On the safety side, 9% of patients in the Provacel group reported the occurrence of cardiac arrhythmia over the six-month observation period, compared with 37% of placebo patients reporting a cardiac arrhythmia. The difference between the two groups was statistically significant, with a p value of 0.025.

There were no patient deaths in the study and fewer adverse events reported by Provacel patients compared with placebo patients. Provacel patients also reported fewer re-hospitalizations and longer average time to hospitalization vs. placebo, although these results were not statistically significant.