Bioheart Makes Breakthrough in Critical Limb Ischemia Therapy with Stem Cells Obtained from Fat Tissue

Press Release, January 4, 2010

Critical limb ischemia is an advanced form of peripheral artery disease, a condition in which plaques accumulate on the blood vessels causing restriction of blood flow. Patients with critical limb ischemia typically have a chronic level of pain and can only be treated by bypass surgery of the leg, or by placement of stents to keep the blood vessel open. Unfortunately, a significant proportion of patients with critical limb ischemia (up to 40%) can not have these procedures performed either because of the shape of the blood vessels, or because of their poor health. For these patients the only option is amputation.

One way of treating critical limb ischemia would be to stimulate the body to produce new blood vessels in the areas that are lacking oxygen. This process of new blood vessel formation, called angiogenesis, is usually the body's natural response to lack of oxygen. Unfortunately in patients with critical limb ischemia the body's ability to stimulate new angiogenesis is not potent enough to cause significant clinical benefit.

Previously researchers have tried to inject the leg muscles of patients with critical limb ischemia with growth factors that stimulate new blood vessels. For example, the company Vical administered the gene for hepatocyte growth factor (HGF) to try to prevent limb amputations. Positive effects seen with this approach allowed Vical to register their therapy for use in Japan. A more potent method of triggering formation of new blood vessels would involve administration of stem cells. Stem cells can directly become new blood vessels, or can stimulate the body's existing stem cells to start making new blood vessels, this is explained in the video Stem Cell Therapy for Critical Limb Ischemia. Studies in the United States by Dr. Michael Murphy have produced positive results by administration of the patient's own bone marrow cells into the muscles lacking oxygen as shown in the video Stem Cell Therapy for Peripheral Artery Disease.

It is important to note that bone marrow extraction can be a difficult procedure to perform in patients with this condition, since it involves puncturing the hip bone to extract marrow. An alternative approach to using bone marrow would be to use stem cells derived from the fat. The company Medistem has previously reported data on patients with multiple sclerosis that were treated with their own fat stem cells in the publication Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis. The advantage of using stem cells from fat tissue is that other types of cells co-purify with the fat stem cells. These include endothelial progenitor cells, which are important in forming new blood vessels, as well as T regulatory cells which have various anti-inflammatory properties and may be useful in suppressing the ongoing tissue damage that is occurring as a result of the lack of oxygen.

Today the company Bioheart announced some of their rationale for use of fat derived stem cells in critical limb ischemia, as well as a collaboration with TGI and a Czech University at clinically implementing fat stem cells.

According to the press release, Bioheart stated that advantages of using fat stem cells for patients with critical limb ischemia include the fact that: a) A large quantity of stem cells can be obtained from a patient's fat (adipose) tissue without pain and other side effects, quickly and cheaply; b) fat stem cells are capable of promoting blood vessel formation and assisting with the healing of damaged blood vessels; and c) Lower limb ischemia is pain, often severe enough to be intolerable, in the lower limb due to limited or inefficient blood circulation.

Bioheart, stated that in collaboration with University Hospital Ostrava in the Czech Republic, it initiated treating patients with critical limb ischemia. The method of fat stem cell isolation and purification being used involves processing by medical devices manufactured by the company TGI systems.

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 therapy allowing natural repair of diseased vessels and tissues by using the patient's own cells. Bioheart's TGI system is able to be used in a number of cardiovascular treatments to aid in the recovery of a normal life. That is Bioheart's goal."

Bioheart has an exclusive license for use of the CE mark approved TGI 1200 System that purifies fat stem cells from fat tissue in approximately an hour.

The University Hospital Ostrava is extremely excited to be a part of this cutting-edge technology and welcomes the studies,'' said Dr. Vaclav Prochazka, MD, PhD, MSc, Head Physician of the Department of Interventional Neuroradiology and Angiology, Vice Director for Research and Development at University Hospital Ostrava, Czech Republic, who has been utilizing the cells for treating his patients. "We believe that this will bring new hope to many patients suffering from critical limb ischemia."