SUNRISE, Fla., Sept. 14, 2011 (GLOBE NEWSWIRE) -- Bioheart, Inc. (OTCBB:BHRT) announced that they will begin a US clinical program called the ANGEL trial utilizing adipose derived cells or LipiCell for congestive heart failure patients. Using the clinical data from a Phase I/II trial in Mexico and preclinical studies, Bioheart will apply to the FDA to begin a Phase I study in the US.
In collaboration with the Regenerative Medicine Institute of Tijuana, Mexico, six congestive heart failure patients have been successfully treated in a Phase I/II trial at Hospital Angeles Tijuana. 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.
The US ANGEL trial design and results from the Mexico trial were presented by Bioheart's Chief Scientific Officer, Kristin Comella at the Stem Cells USA & Regenerative Medicine Congress in Boston this week. She stated, "Safety and efficacy have been successfully demonstrated in the trial at Hospital Angeles and we are looking forward to beginning one of the first US trials using adipose derived cells for congestive heart failure patients."
Bioheart has completed several preclinical studies demonstrating the safety and efficacy of this product including a study led by Keith March, MD, PhD, Director of the Vascular and Cardiac Center for Adult Stem Cell Therapy at the Indiana University. The adipose cells showed a tendency toward cardiomyocyte regeneration, prominent angiogenesis (growth of new blood vessels) and reduction in the infarction size.
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.
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