Bioheart has completed an Investigational New Drug (IND) application to the FDA for the ANGEL trial. The clinical protocol is designed to assess the safety and cardiovascular effects of intramyocardial implantation of autologous adipose derived stem cells (LipiCell) in patients with chronic ischemic cardiomyopathy. Transplantation of LipiCell will be accomplished through endocardial implantations with the MyoStar™ Injection Catheter under the guidance of the NOGA® cardiac navigation system by Biosense Webster, Inc.
The IND submission included results from an ongoing Phase I/II trial in Mexico. Bioheart, in collaboration with the Regenerative Medicine Institute, has successfully treated nine heart failure patients using LipiCell. The therapy involves the use of stem cells derived from the patient’s own fat (adipose tissue) obtained using liposuction. These patients have demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance.
Bioheart’s Chief Scientific Officer, Kristin Comella stated, “We are looking forward to being one of the first companies to bring these therapies to US trials. We have successfully demonstrated the safety and efficacy of adipose cells in preclinical studies as well as our clinical trial in Mexico.”