Clinical Trials outside U.S.: Severe Coronary Artery Disease

SEVERAL CLINICAL TRIALS targeting heart disease have shown that adult stem cell therapy is safe and effective. Adult stem cell therapy for heart disease is commercially available on at least five continents at last count. The most well known of these companies is TheraVitae, a private company based in Bangkok, Thailand, with locations in Kiryat Weiz—mann, Israel; Toronto, Canada; Singapore; Taipei, Taiwan; and Hong Kong. TheraVitae is a private, multinational company focused on using stem cells from the patient's own blood in order to treat a variety of disorders, especially cardiovascular diseases. Research, development, and manufacturing are performed at the company's state—of-the—art cell therapy facility located in Kiryat Weizmann. TheraVitae's plans treatments for optical and neurological diseases in the future.

The company has already developed a proprietary stem cell technology, VesCell, that is currently being used by hospitals in Thailand to treat patients with heart disease. VesCell uses a special process that differentiates the stem cells so that they can build additional blood flow to and from the heart by creating new blood vessels and new heart muscle. While VesCell stem cell treatment may not cure heart disease, it can substantially improve the flow of blood, thus reducing chest pains and sharply increasing physical capacity More than 250 heart patients have traveled to Thailand to receive TheraVitae's adult stem cell therapy. TheraVitae reports that 75 percent of their heart patients have an improved quality of life after receiving adult stem cell treatment. The worldwide results (over 2,000 treated) are similar despite many different types of adult stem cells being implanted into very sick heart patients by doctors in over two dozen countries.

TheraVitae is conducting a clinical trial to study the safety and efficacy of the administration of endothelial progenitor cells to patients with severe angina pectoris. The study, conducted at Siriraj Hospital, the largest hospital in Bangkok, Thailand, will assess the treatment in 24 patients with severe chronic angina who meet certain inclusion and exclusion criteria. Associate Professor Dam—ras Tresukosol of the Cardiac Center at the Siriraj Hospital is the principal investigator in the study. This trial will determine the efficacy and safety [Page 113]of a new heart treatment option for Thais who have severe anginal symptoms despite undergoing another revascularization therapy.

Endothelial progenitor cells, EPCs, are stem cells harvested from the patient's own blood that have the capability to form new blood vessels, or angiogenesis. EPCs are found in the bloodstream, but in a very low concentration. TheraVitae has developed proprietary technologies to harvest, expand and differentiate EPCs to an amount sufficient to induce angiogenesis in the heart. The cells are processed outside the body and then injected into the patient during standard angiography to regions of the heart suffering from reduced blood supply. Injection of EPCs in cardiac patients has proven to increase blood supply to the heart muscle and reduce symptoms of angina in several trials in the United States and Europe.

The potential success of these trials would mean that heart patients would now have another treatment option other than coronary bypass surgery. Furthermore, treating these patients with cell therapy is potentially safer, for the procedure is similar to a cardiac catheterization that is routinely performed to examine a patient's heart function and blood supply. Moreover, employing autologous EPCs (cells taken from the patient himself/herself) eliminates concerns of tissue rejection.

...