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Surgeons inject concentrated stem cells directly into patient’s heart in new clinical trial

Houston, TX - 11/21/2008

Patients with questions about enrolling in the trial can call 713-441-5703.

Surgeons at The Methodist Hospital in Houston were the first in the nation Thursday to inject highly-concentrated stem cells directly into a patient’s heart, providing an intense, direct hit on damaged heart tissue.

In an investigational study of new heart failure treatments, this promising new technique may be more effective in regenerating healthy heart tissue than current methods that use a catheter to put standard stem cells through the bloodstream into the heart.

The 58-year-old veteran and businessman is resting comfortably and is expected to be discharged this weekend.

“Some patients have such severe heart failure that their only current option is a heart transplant,” said Dr. Brian Bruckner, cardiac surgeon at the Methodist DeBakey Heart & Vascular Center in Houston. “We hope that stem cells will stimulate angiogenesis, the growth of new blood vessels, restore mechanical function in diseased heart tissue, and return patients to a much better quality of life without a transplant.”

In a novel process, the patient’s strongest and most robust stem and progenitor cells, derived from the patient’s own bone marrow, are amplified up to 1,000 times before they’re injected back into the patient’s heart. In the procedure, Dr. Bruckner made a small incision in the left side of the patient’s chest and administered approximately 25 injections of concentrated stem cells into the patient’s heart. All patients in the trial will be followed for 12 months after the injections.

There are currently 5.5 million people in the U.S. suffering from chronic heart failure. A subset of these patients has dilated cardiomyopathy (DCM), a chronic heart disease in which the patient's heart can not pump effectively enough to deliver blood and oxygen to the vital organs in the body. Patients with DCM typically experience severe limitations to physical activity and shortness of breath.

“Without a new approach to treatment of these patients, they will continue to decline and less than 40 percent will survive five years,” said Bruckner, principal investigator for the trial. “We hope this trial will provide a completely new and viable treatment for them.”

Dr. Michael Reardon, chief of cardiac surgery at Methodist, and Dr. Matthias Loebe, transplant surgeon at Methodist, are co-investigators on the trial. Dr. Kevin Lisman is the patient’s referring cardiologist.

About the trial

The IMPACT-DCM trial is a randomized, controlled, prospective, open-label, Phase II study that will seek to enroll 20 patients with ischemic dilated cardiomyopathy (DCM) and 20 patients with non-ischemic DCM at five clinical sites in the U.S. The trial is sponsored by Aastrom Biosciences, Inc.

Students from the DeBakey High School for Health Professionals gather around Dr. Michael Reardon, chief of cardiac surgery at The Methodist Hospital, to ask questions following his lecture on the use of adult stem cells to treat heart failure. Reardon was a guest lecturer for the DeBakey High School for Health Professionals’ Scientific Symposium on Friday, Dec. 19, 2008.

Participants must have a left ventricular ejection fraction of less than or equal to 30 percent (60-75 percent is typical for a healthy person) and meet certain other eligibility criteria.

All patients in each group will receive standard medical care and 75 percent of the patients will be treated with cardiac repair cells (CRC), a mixture of stem cells and progenitor cells derived from the patient’s own blood marrow, through direct injection into the heart muscle during a minimally-invasive procedure in the operating room.

While the primary objective of this study is to assess the safety of CRCs in patients with DCM, efficacy measures including left ventricular ejection fraction and other cardiac function parameters as well as heart failure stage will be monitored. Patients will be followed for 12 months post treatment.

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