New medical breakthrough by Bioheart for treatment of patients with heart disorders

Oct 1 2009

Bioheart, Inc. (OTCBB:BHRT) offers yet another medical breakthrough with the next-level stem cell treatment for cardiac patients. The stem cells aid in limiting damage due to a cardiac event and promote angiogenesis or formation of new blood vessels.

Bioheart, in collaboration with Hospital de Clinicas Caracas in Caracas, Venezuela, has already begun three different studies utilizing the ASCs: surgical delivery of cells during a coronary artery bypass grafting (CABG) procedure, percutaneous delivery of cells in chronic heart ischemia and delivery of cells in critical limb ischemia.

Adipose derived stem cells and the TGI 1200 System have three critical advantages: 1) the technique limits damage to heart muscle after an acute injury; 2) the cells serve as a catalyst for new vessel formation; and 3) the system is an easier and faster procedure for obtaining stem cells.

Dr. Karl Groth, Bioheart’s Chairman and CEO commented on the therapy: “Stem cell therapy is not just intended as a temporary solution, but it is developed as a novel adjunctive therapy allowing natural repair of diseased vessels and tissues by using the patient’s own cells.”

“The adipose tissue in the human body can be considered a stem cell reservoir given the large concentration of regenerative cells it contains. This discovery leads to new possibilities and cell therapy treatments in cardiovascular related illnesses,” Dr. Groth added.

Bioheart uses the CE mark approved TGI 1200 System, a fully-automated, point-of-care system that recovers potentially regenerative stem cells from a patient's own adipose tissue in 60 minutes, to obtain the ASCs.

“The Hospital de Clinicas is extremely excited to be a part of this cutting-edge technology and welcomes the studies," said Dr. Nusen Beer, MD, a cardiologist who has been utilizing the cells for treating his patients. “We believe that this will bring new hope to many patients suffering from diseases related to cardiac dysfunction. By injecting ASCs into areas of low perfusion, these regions may become populated with angiogenic ASCs, thereby potentially improving blood supply to the scar and reducing scar size.”

Recent studies have identified adipose tissue as an alternate source of stem cells and the procedure of getting adipose derived stem cells from the patient is simple and easily tolerable by the patient even immediately following a heart attack.

In contrast, the alternative procedure is to use bone marrow to derive stem cells, which is extremely painful and often yields a low volume of stem cells.

The ASC’s treatment comes shortly after another of Bioheart’s recent clinical trials, MARVEL-1 in which the patient’s muscle stem cells or myoblasts are isolated and expanded for use in chronic heart failure. The myoblast treatment, believed to be the most effective for heart failure, is being used in Bioheart’s Phase II/III Marvel clinical trial and has seen very positive results. The MARVEL Program is designed to assess the effects of administering autologous skeletal myoblasts on the functional capacity and quality of life in patients with advanced heart failure.

“Bioheart’s clinical trials and studies are committed to bringing effective minimally invasive treatments that result in the return to a normal life for cardiac patients,” Dr. Groth concluded.