New Stem Cell Study Begins For Heart Failure Patients

The U.S. Food and Drug Administration (FDA) has approved a second clinical trial of stem cell therapy for heart failure patients led by University of Texas Health Science Center at Houston President James T.
Willerson, M.D., with collaborators at the Texas Heart Institute at St. Luke’s Episcopal Hospital.

Announced Feb. 21, the clinical trial will be the first in the United States to use Aldagen Inc.’s Aldesort
product to isolate a unique stem cell population for therapy for advanced heart failure patients.

“We are very excited about the FDA clearance to begin this work at the Texas Heart Institute and St.
Luke’s. We believe these cells have the potential to find a very important place in the future treatment of
patients with heart and vascular disease,” said Willerson and Emerson Perin, M.D., director of New
Cardiovascular Interventional Technology and director of the Stem Cell Center at the Texas Heart Institute (THI), in a joint statement. Willerson is president-elect and medical director of THI.

Willerson and Perin have been conducting a clinical trial at THI using unfractionated, or not separated,
cells taken from the patient’s own bone marrow. The physicians have injected millions of these bone
marrow cells directly into the muscle of the left ventricle (the heart’s main pumping chamber)
along the edge of the damaged area. The procedure, which is conducted in a few hours, has yielded
promising results.

Aldesort isolates a highly potent population of stem cells that have been shown to be more active in restoring blood flow to damaged tissue than unfractionated bone marrow in pre-clinical animal models. Stem cells have the potential to build new blood vessels in damaged hearts, leading to improved function in advanced heart failure patients.

The pilot phase of the study, which involves 10 patients, is designed primarily to test for safety. In all, up to 60 patients will be enrolled in the study and randomized, with half of them receiving stem cells isolated by Aldesort.