Bioheart, Inc. is a biotechnology company focused 100 percent on cell therapy products for the heart. Specialized as such and led by a team of industry experts, Bioheart offers a full-line of cell therapy products for heart failure to serve their clients and is in the midst of the largest clinical trial of its kind involving congestive heart failure patients.
Bioheart’s flagship technologies, MyoCell and MyoCell SDF-1, are myoblasts or muscle stem cells that are intended to improve cardiac function months or even years after a patient has suffered severe heart damage due to a heart attack. The process involves removing tissue samples from a patient’s thigh muscle which are then processed at the Bioheart laboratories using their proprietary cell-culturing process to isolate stem cells. These cells are then injected into scar tissue in the patient’s heart to rejuvenate the muscle. Myoblasts are the only stem cell that has shown the ability to grow contractile muscle in scar tissue and that fact is the foundation of this revolutionary therapy.
The Bioheart products range in function to benefit a patient from the time of incident (the heart attack) to the time of full recovery, including:
• Bioheart adipose derived stem cells – Adipose (fat) tissue is full of endothelial progenitor cells, mesenchymal stem cells and other regenerative stem cells which can be utilized to promote angiogenesis or formation of new blood vessels. These cells can be isolated in approximately 1 hour bedside to the patient and immediately delivered back to the same patient. Bioheart has several clinical trials outside the US using adipose stem cells for acute MI, chronic heart ischemia and critical limb ischemia.
• MyoCath – a disposable needle injection catheter used for the delivery of biologic solutions to a targeted treatment site within the myocardium, the inner wall of the heart.
Presently, the Company is investigating MyoCell in Phase II/III trials under direction of the FDA. Started in 2007 and called “the MARVEL Trial,” the study is a randomized, double-blind, placebo-controlled, multi-center Phase II/III Trial involving 160 patients in North America across 35 different centers such as the Minneapolis Heart, Mayo Clinic, the Cleveland Clinic and Columbia University. Bioheart is hoping to compound upon the positive research concluded during part 1 of the Phase II/III trial in which MyoCell treated patients have improved 91.7 meters in exercise capacity testing while placebo injected patients declined – 4 meters. The company hopes to capitalize by providing a better quality of life for the more than 25 million people that suffer heart failure today.