By Tim Bonfield
The Cincinnati Enquirer
A Northern Kentucky woman has become the first patient in the United States to be treated with a new medication designed to help damaged hearts grow new blood vessels.
The University of Cincinnati's Heart and Vascular Center is one of four medical centers nationwide launching an early-stage clinical trial to test a growth factor protein called FGF1 as a way to relieve chest pain.
The first two patients of 32 expected to be involved nationwide were treated this week at University Hospital. Constance Donley, 51, of Cold Spring, Ky., was treated Monday and was released Thursday. Dayton, Ohio, resident Claudia Robertson, 54, was treated Wednesday and remains in the hospital.
Donley suffered her first heart attack in 1995. Since then she has had three open-heart surgeries to bypass clogged arteries. In 2002, she traveled to the Mayo Clinic in Minnesota for an operation.
But not long after that treatment, her chest pain - called angina by the medical world - returned. Most days, the pain is a 3 or 4 on a 10-point scale, she said. But sometimes it's a 10.
"I can't do anything then. The pain is so bad it's even hard to remember my name," Donley said.
The study is sponsored by the product maker, CardioVascular Genetic Engineering of Tustin, Calif. The procedures were performed by Dr. Walter Merrill, chief of cardiothoracic surgery at UC.
The procedure involves injecting the growth factor directly into the heart. In theory, it will trigger new blood vessel growth that helps route blood flow around blocked arteries. The better blood flow, in turn, should relieve the chest pain, doctors say.
Patients will be checked several times over six months to track blood vessel growth and changes in angina.
Angiogenesis - the process of inducing blood vessel growth - has been studied with mixed success by many medical centers.
This project attempts to duplicate some promising results reported during the past few years by researchers in Europe, said Dr. Lynne Wagoner, director of cardiac services at University Hospital and principal investigator.
"The exciting thing about the studies in Europe is that the positive benefits have continued as long as three years after treatment," Wagoner said.
If the first 32 patients experience enough benefits, testing would be expanded to hundreds of patients at several medical centers. That means it could be several years before this treatment is widely available.
E-mail tbonfield@enquirer.com
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