First Clinical Trial of Stem Cell Therapy to Treat Peripheral Artery Disease Underway in Thailand
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TheraVitae Ltd. announced that the first clinical trial using its autologous adult stem cells from peripheral blood to treat patients suffering from severe Peripheral Artery Disease (PAD) of the lower limbs has commenced at Siriraj Hospital in Bangkok, Thailand.
April 12, 2006 -- TheraVitae Ltd., an Israeli-Thai biotechnology company specializing in adult stem cell therapies, recently enrolled its first patient in a clinical trial to study the safety and efficacy of the administration of autologous adult stem cells to patients suffering from severe Peripheral Artery Disease of the lower limbs. Principle Investigator of the study, being conducted at Siriraj Hospital, the largest hospital in Bangkok, is Associate Professor Pramook Mutirangura, Head of Vascular Surgery, Faculty of Medicine, Siriraj Hospital. Dr. Mutirangura administered cells to his first patient on April 11, 2006.
“The research and medical teams at TheraVitae and Siriraj Hospital are very excited to see this highly anticipated clinical trial commence," commented Public Relations Manager, Jay D. Lenner Jr. “We are optimistic that the results will pave the way for doctors to offer this treatment to all no-option PAD patients before the end of the year,” he added.
Peripheral Artery Disease (PAD) is a near-pandemic condition that threatens millions with loss of limbs and even life. PAD is the result of narrowing arteries that, in turn, reduce the blood supply to regions of the body. The current trial will treat severe PAD of the legs, a disease that interferes with walking and often leads to the amputation of toes, feet and legs. Researchers envisage that adult stem cell therapy will enable patients' own bodies to repair damaged blood vessels and grow new ones, thus restoring blood flow and oxygen to damaged tissues.
TheraVitae executives are confident this new product will follow in the successful footsteps of VesCell™, the company’s proprietary therapy for heart disease which has been used to treat over 100 patients including Hawaiian entertainer Don Ho. Co-Founder Mr. Don Margolis expects this new treatment to create a revolution in vascular therapy; one that could, in due course, save tens of thousands of limbs and ultimately lives each year. "This is an incredibly important treatment because we may soon have the ability to restore the blood supply to tissues that have been damaged from lack of blood supply. This treatment has the potential to not only save, but return function to, limbs that previously may have been amputated,” remarked Mr. Margolis.
TheraVitae is supplying its latest generation of Angiogenic Cell Precursors (ACPs) for the clinical trial. TheraVitae takes stem cells from the patient's own blood, differentiates them into ACPs, and then expands them into a therapeutic dose. The brand name for this new cell population specifically differentiated for treating PAD has not yet been released.
About Peripheral Artery Disease
Peripheral Artery Disease (PAD) affects tens of millions of people worldwide, most of whom are not aware that they have the disease. It is especially common in smokers, diabetics, those with high cholesterol levels (hypercholesterolemia) and people who lead a sedentary lifestyle. It can, however, occur in anyone who is aging.
PAD consists of atherosclerosis, a progressive disease that involves the hardening and narrowing of many of the body's arteries due to a gradual buildup of plaque (fatty deposits). The narrowing of the arteries reduces the blood supply to the affected organs, such as the limbs, eyes and brain and reduces their ability to function normally.
Specific cases of PAD are of the heart, in which the disease process may lead to heart failure; of the brain where it can lead to a stroke and progressive deterioration (vascular dementia); and of the eyes where it may cause a decrease in vision.
PAD of the legs can make walking difficult or impossible due to the pain caused by limited blood supply to the legs. Progression of PAD of the legs is the most common cause of amputation of toes, feet and other parts of the legs which degenerate due to the lack of blood supply caused by the progressive narrowing of the blood vessels leading to the legs.
A patient with PAD has about five times the risk of dying of a heart attack or stroke over the next ten years as the patient who does not have peripheral arterial disease.
More information on PAD can be found on the American Heart Association website: http://www.americanheart.org/presenter.jhtml?identifier=4692
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