This week, for the first time in humans, a heart failure patient received adult stem cells – taken from his own adipose (fat) tissue – which were processed and injected directly into the heart muscle with a special catheter. Francisco Fernandez-Avilés, M.D. performed the procedure in Madrid. The Texas Heart Institute at St. Luke’s Episcopal Hospital is leading the collaborative clinical trial which will involve 30 patients.
The trial site for the study is Hospital General Universitario Gregorio Marañón in Madrid, Spain. Dr. Fernandez-Avilés, Professor of Cardiovascular Medicine and Chief of Cardiology Service at Gregorio Marañón and Dr. Perin, Director of New Interventional Cardiovascular Technology and Director of Stem Cell Center at the Texas Heart Institute at St. Luke’s will serve as co-principal investigators.
The procedure involves removing adult stem cells from adipose tissue just as in a liposuction procedure. The cells are processed with a proprietary process developed by Cytori Therapeutics, Inc. After about one hour of processing, the stem cells are injected directly into damaged but viable areas of the heart muscle through an investigational device called a NOGA catheter. This catheter allows three-dimensional color-coded maps of the mechanical and electrical function of the heart’s left ventricle.
“This is the first time we have used adipose-derived stem cells in humans. We had good results in our pre-clinical tests and we are excited about taking this research to the next level,” said Dr. Perin.
A variety of clinical functional and imaging endpoints will be assessed in the study. The outcomes of the study will be evaluated after a six month follow up. The doctors expect to present the six month outcomes of the study in 2008.
“This is another significant advance in our international collaboration to find solutions to heart failure and other cardiovascular diseases through adult stem cell treatment. The Texas Heart Institute at St. Luke’s has been conducting the first FDA-approved adult stem cell study for heart failure patients using stem cells taken from the patients’ own bone marrow. We have almost completed enrolling the final patient in that 30-patient study and look forward to sharing those results later this year,” said James T. Willerson, M.D., president-elect and medical director of the Texas Heart Institute at St. Luke’s. Dr. Willerson is also president of The University of Texas Health Science Center at Houston.
Heart failure is a condition in which the heart can’t adequately pump sufficient blood to the body’s other organs. It is the only cardiovascular condition which continues to rise in the U.S. More than half a million Americans are diagnosed with heart failure each year.
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