er stem cells take on the functional characteristics of heart cells or blood vessels, or whether they help recruit other cells and growth factors that have the ability to help regenerate heart tissue. Our study presents the unique opportunity to examine the heart several months after stem cell injections, when the patient's native heart is removed for organ transplantation, and we're hopeful we'll find the answers to everyone's questions," noted Amit N. Patel, M.D., M.S., principal investigator of the clinical trial and director of UPMC's Center for Cardiac Cell Therapy. Dr. Patel also is director of the Center for Cardiovascular Cellular Therapy at the McGowan Institute for Regenerative Medicine.

UPMC plans to enroll five to 10 patients. To qualify, patients must have congestive heart failure and require implantation of a ventricular assist device (VAD) as a bridge to transplantation.

Unlike the other FDA-approved trials, surgeons will not deliver the cells through a catheter leading into the heart's coronary arteries but will instead inject them directly into the diseased heart tissue during the VAD implant surgical procedure. With the patient under anesthesia, Dr. Patel's team will harvest bone marrow from the patient's hipbone, and the cells believed to have the greatest therapeutic benefit, CD34+ cells, will be isolated. About three hours later, once the VAD has been implanted and connected to the heart's main pumping chamber, the ventricle, the cells, together with a small amount of the patient's blood plasma, will be injected into about 25 to 30 sites of the diseased heart in a process taking no more than five minutes. Depending on their weight, each patient will receive between 25 and 45 million stem cells.

In order to help the researchers better understand what effects the stem cells have on the cellular structures that surround the injection sites, they also will give patients injections containing only plasma to a different area of
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12-May-2005

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