Heart Disease Therapy Cleared for Phase 2 Clinical Trial to be Funded by Stem Cell Agency

A stem cell therapy aimed at treating patients who have had a heart attack has been given approval to begin a Phase 2 clinical trial funded by California’s stem cell agency, the California Institute for Regenerative Medicine (CIRM).

 The treatment, developed by Capricor Therapeutics, Inc., uses unrelated donor-derived stem cells, called cardiosphere-derived cells, that are then infused into a patient’s artery with the aim of reducing scarring caused by heart attacks. In a Phase 1 clinical trial designed to test the safety of the therapy, the cells were introduced into 14 patients and were found to be safe.

The next phase will involve an estimated 300 patients who have had heart attacks, and they will be evaluated in a double-blind, randomized, placebo-controlled trial.  This will be further broken down into two groups: one will include patients 30-90 days post attack, the second will be 91 days to one year after the incident.