Penn State Hershey Medical Center administers treatment to first patient in Pennsylvania
Penn State Milton S. Hershey Medical Center has opened a new trial to investigate the effectiveness of a drug that may promote new blood vessel growth in the heart and could eventually provide an alternative to open heart surgery for the millions of Americans with coronary artery disease.
The trial, sponsored by CardioVascular Genetic Engineering, a biopharmaceutical company based in California, tests an experimental drug called Human Fibroblast Growth Factor-1, a slight variation of which already was tested in Germany. The study has been approved by the Institutional Review Board under Food and Drug Administration regulations at Penn State College of Medicine.
"We're trying to stimulate people to grow their own bypasses," said John P. Boehmer, M.D., principal investigator for the Penn State Hershey Medical Center study site, and associate professor of medicine, Penn State College of Medicine. "After administering the treatment, it will take up to six months until we'll know for sure whether there's regeneration of blood vessels in the heart."
Although this trial is investigating whether FGF-1 will cause blood vessel growth, called angiogenesis or neovascularization, growth of new blood vessels is a common response to injury. People with blocked arteries in their hearts also may naturally grow new blood vessels. However, the new blood vessels often do not supply enough blood to the heart. The trial investigates whether FGF-1 stimulates the growth of many more new blood vessels that can improve and provide adequate blood flow to the heart.
The trial only will include patients with inoperable coronary artery disease who also meet a number of other criteria. Those patients interested in participating undergo an extensive informed consent process as well as a number of tests to pre-qualify for the trial. If the patients qualify and choose to participate, Walter E. Pae, Jr., M.D., cardiac surgeon, Penn State Hershey Medical Center, administers the drug by making a small incision in the chest and then injecting the FGF-1 via the incision into the heart muscle.
After the treatment, patients will undergo a number of tests and assessments to check for blood vessel growth. One test will be an eye exam because the eye is an early responder to stimulation of blood vessel growth. Patients will have six follow-up visits.
A resident of Washington state, the first patient at Penn State Hershey Medical Center was treated with FGF-1 Dec. 15 and was released the next day.
In addition to effectiveness, the study will examine different doses of the growth factor. The study will include a total of 32 patients over three study sites, which include Penn State Hershey Medical Center, St. Joseph Medical Center in Towson, Md., and University of Cincinnati. Penn State Hershey Medical Center was the first of four trial sites nationwide to meet all study regulations and open the trial.
Previous human studies using a slightly different formulation of the drug were conducted in Germany. In that study sample, FGF-1 appeared to stimulate new blood vessel formation in patients with severe heart disease.
For inclusion criteria and other information about the trial, visit the National Institutes of Health clinical trials web site at http://www.clinicaltrials.gov and search for FGF-1. To contact a clinical trial coordinator at Penn State Hershey Medical Center, call (717) 531-6855.