SUNRISE, FL, Sep 26, 2013 (Marketwired via COMTEX) -- Bioheart, Inc. (OTCQB: BHRT), a biotechnology company focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage, announced today preliminary data from its phase I ANGEL Trial. Fully funded by Bioheart, the trial is being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute (RMI).
"The preliminary Phase I data has far exceeded our expectations. In addition, the strong safety profile demonstrated will allow us to expand this study to additional clinical sites and enroll more patients," said Kristin Comella, Bioheart's Chief Science Officer. This phase I study will provide necessary safety and preliminary efficacy of adipose derived stem cells (AdipoCell(TM)) in patients with congestive heart failure. Endpoints include safety, exercise capacity, quality of life, and ejection fraction at 3 months, 6 months and 12 months.
At the 3 month time point, patients are demonstrating an average improvement in exercise capacity or a six minute walk test of 47 meters. In addition, 60% percent or a majority of the patients are walking greater than 65 meters further at 3 months post stem cell injection.
The patients are also reporting an average improvement of 13 points in their Minnesota Living with Heart Failure questionnaire. An improvement of 5 points or greater is considered "clinically meaningful" and 80% of the patients in the trial had a greater than 5 point improvement.
About Bioheart, Inc.
