Osiris Therapeutics, a stem cell therapeutic company, has started treatment of the first patient in a Phase II clinical trial evaluating Prochymal for the treatment of heart attacks.
The Phase II double-blind, placebo-controlled trial will evaluate the safety and efficacy of Prochymal in conjunction with standard of care to improve heart function in patients who experienced a first heart attack. The trial will be conducted at leading institutions and academic research centers in the US and Canada. This trial focuses on patients who have suffered a severe myocardial infarction.
The target enrollment is 220 patients, and patients will be randomized to either Prochymal or placebo at 1:1. Efficacy endpoints determined from cardiac MRI include end systolic volume, left ventricular ejection fraction and the ability of Prochymal to preserve functional heart tissue, or limit scar formation following a heart attack. In addition, functional and quality of life assessments will be performed.
Roger Gammon, medical director of research at Austin Heart, said: The excellent safety profile and encouraging data from the Phase I trial makes Prochymal a promising therapy for the treatment of acute myocardial infarction.
This trial will provide valuable data on the ability of these cells to prevent pathological remodeling, which is expected to have positive long-term implications for improved clinical outcomes in patients following a heart attack.