FDA APPROVES CLINICAL TRIAL OF STEM CELL THERAPY FOR ADVANCED HEART FAILURE PATIENTS
(Adapted from the following source: Texas Heart Institute.)

Physicians of the Texas Heart Institute and St. Luke's Episcopal Hospital announced today they have received approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical trial of stem cell therapy. It is believed to be one of the first clinical trials of stem cell therapy for heart failure patients in the United States, and continues this team's earlier trial as one of the first studies in the world to focus on advanced heart failure patients.

For more than a year, Drs. James Willerson, Emerson Perin and Yong Jian Geng have been conducting a clinical trial in Brazil in conjunction with Dr. Hans Dohmann and his colleagues at the Pro-Cardiaco Hospital in Rio de Janeiro. Using a special catheter which is threaded through the groin, the doctors use an innovative mapping technology to identify areas in the heart which have sustained mechanical and electrical damage. Using that same catheter, doctors can inject millions of stem cells directly in the left ventricle along the periphery of the damaged area. The procedure, which is conducted in a few hours, has yielded promising results.

In their initial study, the doctors saw functional improvements as early as six weeks after the procedure. After four months, the patients had increased blood flow to heart muscle as well as improvements in symptoms and the contraction of the heart. Laboratory studies done by members of this same physician group have shown that the stem cells generate new blood vessels and some new heart muscle cells.

Anecdotally, some patients in the Brazil study have returned to work and others are involved in regular exercise, such as walking and running.

The first phase of the study, which involves six patients, is specifically designed to test for safety. After the FDA approves that phase, the study will focus on the efficacy of the treatment. In all, 30 patients will be randomized, with half of them receiving the stem cells in the next phase of the trial.

"We are very excited about the FDA approval to begin this work in the Texas Medical Center at the Texas Heart Institute and St. Luke's. We believe stem cell therapies will find a very important place in the future treatment of patients with heart and vascular disease," said Drs. Willerson and Perin. Dr. Willerson is medical director and director of Cardiology Research at the Texas Heart Institute, and chief of Cardiology at St. Luke's. Dr. Perin is director of New Cardiovascular Interventional Technology at the Texas Heart Institute and St. Luke's.

Because the FDA has limited the initial study to 30 people and considerable follow-up monitoring is involved, the hospital is currently screening only those candidates who live in the greater Houston area and surrounding communities. For more information on the study or to volunteer to participate, please visit the following websites www.texasheartinstitute.org or www.stlukestexas.org.