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University of Cincinnati Academic Health Center
Publish Date: 11/06/03
Media Contact: AHC Public Relations, (513) 558-4553
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UC Doctors First in U.S. to Test Growth Factor Protein in Heart Patients

Physicians from the University of Cincinnati Heart and Vascular Center have performed the first growth factor protein (FGF1) injection in a heart patient to aid in the growth of new coronary vessels.  The protein, FGF1, was injected directly into the heart muscle of a patient on November 3 at The University Hospital. 

This cutting-edge procedure is part of a phase I clinical trial testing the efficacy of using FGF1 for angiogenesis, the growth of new blood vessels, in patients with angina due to coronary artery disease.  The  UC Heart and Vascular Center, in conjunction with The University Hospital, is one of only four sites nationwide to participate in the trial, which is sponsored by CardioVascular Genetic Engineering of Tustin, California.  Thirty-two patients will be enrolled in the national trial.

Walter H. Merrill, MD, chief of cardiothoracic surgery at UC, performed the protein injection.  He was assisted by Thomas Stegmann, MD, professor and chief of cardiovascular surgery at Fulda Medical Center, Fulda, Germany.  Dr. Stegmann has worked on the discovery and development of this growth factor for 10 years, and performed the first procedure of this kind in the world. 

The patient, 51-year-old Constance Donley of Edgewood, Ky., is being released from The University Hospital today.  A second patient, 54-year-old Claudia Robertson of Dayton, Ohio, underwent surgery on Wednesday, Nov. 5, to be the second person in the U.S. to have the procedure.

During the procedure, patients receive 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 blood vessels, which in turn provides alternate routes for oxygenated blood to reach the heart muscle.  FGF1 has the potential to provide an additional treatment option for those whose coronary artery disease cannot be adequately treated
by the most common methods, such as bypass surgery, angioplasty and medications.

Lynne Wagoner, MD, associate professor, UC Department of Internal Medicine/Division of Cardiology, is the director of Cardiac Services at The University Hospital.  Dr. Wagoner is the director of clinical trials at the new UC Heart and Vascular Center, and is the principal investigator for this trial. 

"Some people have such severe coronary artery disease that conventional treatments such as stents or bypass surgery aren't an option for them," said Dr. Wagoner.  "Angiogenesis represents a very promising treatment for the future."

"This is an exciting new therapeutic option for patients who cannot be improved by any other means," said Dr. Merrill.  "Angiogenesis holds great potential to benefit patients in the future. Monday's procedure is representative of important collaborations between medical and surgical specialties that results in a spectrum of extraordinary care for patients with advanced heart disease."

Angiogenesis occurs in an orderly series of complex events: Diseased or injured tissues produce and release proteins called angiogenic growth factors, which bind to specific receptors located on the cells of nearby blood vessels.  The cells begin to produce new molecules including enzymes, then divide and migrate outward, forming new blood vessels.  Individual blood vessel tubes connect to form a network for circulation, and specialized muscle cells provide structural support to these newly formed vessels to facilitate blood flow throughout the body.

The healthy body controls angiogenesis by balancing growth proteins with angiogenic inhibitors; the interaction between the two serves as an "on" and "off" switch for new growth.  When growth factor proteins are produced in excess of inhibitors, blood vessel growth is more likely.

UC Heart & Vascular Center is the marriage of cardiologists, cardiothoracic surgeons, and vascular surgeons, from the UC College of Medicine, to diagnose and treat cardiovascular and peripheral vascular diseases.  UC Heart & Vascular Center physicians and surgeons follow patients at The University Hospital, University Pointe, and The Christ Hospital Medical Office Building.  For additional information, please call 888-5UC HEART (888-582-4327).

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