( development for the treatment of patie...)Feds give researchers ok for safety test of adult stem cells in patients with heart disease

"Traditionally, physicians have been able to prevent heart attack or alleviate its after-effects, but they have not figured out how to initiate the sort of blood vessel repair that remains a key to survival," says Dr. Laughlin. "Now there is a promise of achieving that repair by infusing highly selected marrow stem cells."

Upon acceptance in the study, patients with blocked or damaged heart vessels will be assigned to one of three groups, each made up of three to four patients who will receive a preset dose of stem cell therapy. They will have stem cells drawn from their own bone marrow. These cells will then be enriched in the laboratory and injected into the patients at the site of their ischemia.

The Phase I study is being conducted at University Hospitals of Cleveland with support from the National Institutes of Health, Case Western Reserve University, and Cleveland-based Arteriocyte.

Blocked or damaged blood vessels are a major cause of illness and death around the world. Atherosclerosis, for example, can lead to congestive heart failure and heart attacks. About 5 million people in the United States have heart failure and the number is growing. Each year, another 550,000 people are diagnosed for the first time. It contributes to or causes about 300,000 deaths each year. About 1 percent of the U.S. population over the age of 65 is diagnosed with congestive heart failure each year. Existing therapies include drugs, gene therapy, and vascular interventions for relief of arterial obstructions.

In 2003, approximately 750,000 coronary artery bypass graft (CABG) surgeries were performed worldwide and approximately 1.8 million balloon angioplasty procedures were performed. While these interventional therapies are now the standard of care, there are still a significant number of people for whom these methods do not work, or who have blockage throughout their bodies.