Bioheart stated it will begin a U.S. clinical program utilizing adipose cells for congestive heart failure patients. In what it is calling the Angel trial, the Sunrise, Fla.-based company will use data from a Phase I/II trial in Mexico and clinical studies to apply to the FDA to start a Phase I study in the U.S.
Bioheart reported that the Regenerative Medicine Institute of Tijuana, Mexico, has successfully treated six congestive heart failure patients using stem cells derived from a patient’s own body fat.
“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 Indiana University," the company stated. “The adipose cells showed a tendency toward cardiomyocyte regeneration, prominent angiogenesis and reduction in the infarction size.”