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April 2004 Issue

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UC Heart & Vascular Patients Grow New Coronary Arteries

Published April 2004

Three patients at UC and The University Hospital have grown new coronary arteries after receiving a growth factor protein (FGF1) in November 2003. All three patients showed improved blood flow to the heart three months following the injection.

UC Heart & Vascular physicians were the first in the U.S. to inject this protein in heart patients in an attempt to grow new coronary arteries. The procedure is part of a phase I clinical trial, measureing the safety and effectiveness of FGF1 to grow new arteries, termed angiogenesis, in patients with angina (debilitating chest pain) due to severe coronary artery disease. UC is one of only four sites nationwide to participate in the trial, which is sponsored by CardioVascular Genetic Engineering of Tustin, California. Nationally, 32 patients will be enrolled.

Thomas Stegmann, MD, professor and chief of cardiovascular surgery at Fulda Medical Center in Fulda, Germany, worked on the discovery and development of this growth factor, and performed the first procedure in the world.

"Some people have such incapacitating chest pain and severe coronary artery disease that conventional treatments such as stents or bypass operations aren't an option," said Principal Investigator Lynne E. Wagoner, MD, associate professor of medicine, UC College of Medicine, and direc-tor of cardiac services at The University Hospital. "Angiogenesis represents a promising treatment alternative. UC is pleased to be the first center in the nation to offer the growth factor protein treatment to patients. Dr. Stegmann's European results are compelling."

Angina affects more than 6 million Americans and may lead to heart failure. It is often managed by medication, and in more severe cases, with angioplasty, stenting and/or coronary artery bypass surgery. Angiogenesis treatment is an important breakthrough for patients who have run out of options and are at risk for developing heart failure.

The three American patients who received this growth factor protein are: Constance Donley, 51, of Cold Spring, Kentucky; Claudia Robertson, 54, of Kettering, Ohio; and James Duke, 57, of the Forest Park area of Cincinnati. Before treatment, Donley found it difficult to work a full day and was nearly crippled by constant chest pain.

Patients are invited to participate in the clinical trial after meeting stringent criteria. Dr. Wagoner; Daniel Snavely, MD, assistant professor and interventional cardiologist at UC; and Walter H. Merrill, MD, professor and chief of UC's Divison of Cardiothoracic Surgery, work together to conduct tests to determine if standard therapy is no longer an option for patients and if they qualify for this study. Dr. Merrill injects FGF1 directly into the heart muscle of the patient. Each patient receives up to two injections of the growth factor protein during minimally-invasive, beating-heart surgery. Supplementing the heart with the growth factor protein can result in the growth of new arteries.

Patients are evaluated through cardiac catheterization screenings three months following the injection. Dr. Snavely uses angiographic dye to detect any new artery growth. In the first three patients enrolled in the |trial, FGF1 did, in fact, lead to new vessel formation and can be seen as a "blush" during cardiac catheterization. New arteries result in more blood flow, and therefore increased oxygen delivered to the heart muscle. All patients are reporting little or no chest pain and the ability to do more physical activity than before receiving the injection.

Coronary artery disease affects 12 million Americans and it is estimated that the related costs of this disease are more than $100 billion per year in the U.S. The use of the FGF1 growth factor protein may also have significant application in the treatment of stroke or other problems consisting of de-creased blood flow to the brain, or in peripheral vascular disease when there is diminished blood flow to the legs.

"This process is exciting for us as doctors, because it represents important collaborations between medical and surgical specialties that result in a spectrum of extraordinary care for patients with advanced heart disease," said Dr. Merrill.

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