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STUDY OF FETAL PIG CELLS TRANSPLANTS FOR PATIENTS WITH PARKINSON'S DISEASE BEGINS AT UNIVERSITY OF SOUTH FLORIDA
Tampa, FL (March 17, 1998) ---- The University of South Florida College of Medicine is the lead center for a national study investigating the safety and effectiveness of fetal pig tissue transplantations for patients with advanced Parkinson's disease.
Surgeons at two centers -- USF and Emory University in Atlanta -- will transplant the fetal brain cells of pigs into the damaged brains of patients with Parkinson's.
Researchers hope the surgical treatment will offer relief to patients whose debilitating symptoms are no longer controlled by medications. Furthermore, they continue to seek more readily available alternatives to embryonic tissue for the long-term treatment of Parkinson's disease, which afflicts more than 1 million Americans.
Four clinical centers -- USF, Emory, Columbia University in New York City and Boston Medical Center -- will evaluate the 36 patients and monitor their progress following the transplantations. The study is sponsored by Diacrin/Genzyme LLC, a pharmaceutical company.
The second-phase clinical trial follows an initial study of 12 patients, conducted by Boston Medical Center and Harvard Medical School, which demonstrated no major complications with the cross-species transplants and some improvement in patients' symptoms.
"This larger clinical trial will help us definitively determine whether the transplants with porcine tissue work." said Thomas Freeman, MD, the USF neurosurgeon who will perform the fetal porcine cell transplants at Tampa General Hospital.
Dr. Freeman, director of the Neural Reconstruction Program at TGH/USF, was the first neurosurgeon to successfully transplant pig tissue into an animal 10 years ago. He is one of two neurosurgeons in the country conducting National Institutes of Health-funded studies of human tissue transplantation for the treatment of both Parkinson's and Huntington's diseases.
Robert Hauser, MD, associate professor of neurology, pharmacology and experimental therapeutics and director of the USF Movement Disorders Center, will recruit and evaluate the patients undergoing transplants at TGH.
In the Boston study, all patients received fetal porcine cells on one side of their brains only. In the randomized, controlled study led by USF, porcine cells will be implanted on both sides of the brain.
"By transplanting a larger number of cells into both sides of the brain, we hope to increase cell survival and improve patient outcomes," Dr. Hauser said.
Pigs would be the leading candidate to supply cells for people, Dr. Freeman said, because they are widely available and porcine tissue is well tolerated when it is used to treat other diseases. Porcine tissue is routinely used, with few complications, in the repair of heart valves, and in the past was a common source of insulin.
"We've entered a new era in neuronal transplantation," Dr. Freeman said. "The race is on to find appropriate cell lines that can be used to treat the large number of people with Parkinson's and other neurodegenerative disorders.
USF is at the forefront of neuronal transplantation research. Dr. Freeman's group was the first in the world to prove that human fetal tissue transplants can survive in patients with Parkson's disease and improve symptoms.
Last month, researchers here and at the University of Pennsylvania announced that stem cells taken from a rare human cancer and differentiated into neurons restored the function of rats subjected to experimental stroke. In addition, USF is exploring the clinical potential of cells from the testes, known as Sertoli cells, in treating Parkinson's, stroke and other neurodegenerative disorders.
For more information on the porcine cell transplantation study, call the patient information line at the USF Movement Disorders Center in Tampa at (813)253-4455.
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