Bioheart, Inc. - (OTC Bulletin Board: BHRT) The mission of the Cell Therapy Foundation is to improve public health through the support of effective adult stem cell research and education. The Foundation aims to promote basic and applied knowledge, processes and cell therapies. As part of this mission Cell Therapy Foundation provides updates concerning advances in adult stem cell research. A recent initiative tabulating clinical trials involving cell therapy identified Bioheart's MyoCell as one of only a few cell therapies that are presently in the Phase III stage of clinical trials in the United States. MyoCell has shown the ability to improve heart function in patients suffering from heart failure.
At the Heart Failure Society of America Annual Meeting, Bioheart presented interim results from their randomized, double blinded, placebo controlled Phase II/III clinical trial called MARVEL. The MARVEL study focused on treating significant scar tissue damage caused from a previous heart attack in advanced heart failure patients. The results were outstanding. MyoCell treated patients improved 91.7 meters in the six minute walk test, while the placebo patients declined 4 meters.
Dr. Warren Sherman, Lead Investigator of the MARVEL trial and Director of Stem Cell Research and Regenerative Medicine at Columbia University Medical Center stated, "The early positive clinical results from Bioheart's MyoCell are truly an example of how far along adult stem cell research has come. We are very close to proving the value of adult stem cell therapy for a major unmet indication such as heart failure. This is very exciting to all of us in the field."
Bioheart's MyoCell is a composition of immature myoblasts or adult muscle stem cells derived from a biopsy of a patient's thigh muscle. This muscle biopsy is sent to Bioheart's cGMP laboratory where the muscle stem cells are isolated and expanded. The cells are delivered directly into the scar tissue of the heart using Bioheart's MyoCath, a deflecting tip needle catheter. These stem cells may form contractile muscle in the scar tissue of damaged hearts.
Howard J. Leonhardt, Founder of Bioheart, Inc., Chief Scientific and Technology Officer as well as Chairman of their Scientific Advisory Board added, "The Bioheart investigators and our internal team are truly honored by this recognition from the Cell Therapy Foundation. Only our cell type has demonstrated an ability to form contractile muscle in scar tissue, which differentiates our clinical trial from all others."