Bioheart, a developer of cell-based therapies for cardiovascular diseases, has been granted FDA approval to proceed with a Phase I clinical trial for a potential congestive heart failure treatment. Bioheart’s MyoCell SDF-1 therapy modifies stem cells from the patient’s thigh muscle to create a particular protein. MyoCell believes that the cells, when injected, have the potential to stimulate cell repair and muscle growth in damaged hearts. If approved, MyoCell SDF-1 would be the first combination gene and stem cell therapy for cardiovascular disease on the market. The 15-patient trial is expected to begin later this year.
With congestive heart failure, the heart doesn’t pump enough blood, causing blood to back up in the veins. Fluid builds up in the body and causes swelling in the patient’s extremities. Congestive heart failure can be caused by a variety of factors, such as clogged arteries, prior heart attacks, or high blood pressure. According to the American Heart Association, approximately 5 million people in the U.S. are living with congestive heart failure.
Heart failure patients are typically treated with drug regimens and/or cardiac resynchronization devices such as pacemakers. A number of companies are working to find new treatments for this widespread disease. Companies working in this field include Symphony Medical, Sunshine Heart, Paracor Medical, ABIOMED, ORQIS Medical Corporation, and BioVentrix.