Bioheart Files With the FDA to Begin the ANGEL Trial
SUNRISE, Fla., Dec. 6, 2011 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced that they have 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. – A Johnson & Johnson Company.
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."
About Bioheart, Inc.
Bioheart is committed to maintaining our leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Our goals are to cause damaged tissue to be regenerated, if possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.
Specific to biotechnology, we are focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Our leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.
For more information on Bioheart, visit http://www.bioheartinc.com.
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CONTACT: Bioheart, Inc. Catherine Sulawsk-Guck Chief Operating Officer 954-835-1500