FDAnews
www.fdanews.com/articles/85840-osiris-completes-enrollment-in-stem-cell-trial

OSIRIS COMPLETES ENROLLMENT IN STEM CELL TRIAL

April 5, 2006

Osiris Therapeutics has completed enrollment in a human clinical trial designed to evaluate the safety and preliminary effectiveness of its universal adult stem cell drug candidate Provacel, being developed to treat patients suffering from heart attacks. A total of 53 patients were enrolled in the Phase I trial at ten leading heart centers across the country.

Provacel is a formulation of adult stem cells being developed to repair damaged heart tissue. A key feature of Provacel is that it is given to patients through a standard IV line. In preclinical studies, the cells responded to chemical signals given off by the heart following injury. These signals attracted the cells specifically to the area of injury, where they participated in repair.