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| |  ANA: Pig Fetal Cells Fail To Improve Condition In Patients With Parkinson’s Disease By Ed Susman Special to DG News CHICAGO, IL -- October 1, 2001 -- Transplanted porcine fetal cells failed to improve outcomes when compared to a placebo procedure for patients with Parkinson’s disease. "Based on the outcome of this study, we cannot recommend this procedure for treatment of Parkinson’s disease," said Dr. Robert Hauser, MD, professor of neurology at the University of South Florida, Tampa, speaking yesterday (September 30) at the 126th annual meeting of the American Neurological Association. Dr. Hauser and colleagues transplanted fetal tissue harvested from pigs into the brains of 10 patients with Parkinson’s disease and performed sham surgery on seven other patients. The sham surgery included making an incision in the scalp and boring a partial burr hole into the skull, similar to the start of the stereotactic procedure in which 48 million cells were transplanted into the patients who received the active treatment. Those who received the cells also were given doses of cyclosporine and prednisone to protect against rejection of the cells. The patients who received the sham surgery also received placebo cyclosporine and prednisone. The mean improvement over baseline was about 25 percent for patients who received the pig cells versus 21 percent improvement for patients who received the placebo treatment, Dr. Hauser said. The differences were not statistically significant. Improvement was based on uniform Parkinson’s disease response scale scoring. In looking at secondary end points, Dr. Hauser said the improvement seen in motor function was essentially the same in both the treated and placebo groups-about a 31 percent improvement. He said that the robust placebo effect was similar to what has been observed in other placebo-controlled studies involving Parkinson’s disease. The researchers could not discern a statistically significant difference between the groups in the percentage of waking hours spent in the OFF state, nor in the number of waking hours spent in the ON state, or in the investigators global evaluations of the patients. Those results again suggested that the treatment was not effective, he said. He said that none of the patients who received the pig cell implants appeared to have developed any infections with porcine endogenous retrovirus or other treatment-related infections. Dr. Hauser said researchers will continue to study the patients to determine if the fetal cells survived in the brain. "Transplanted human fetal mesencephalic tissue survives and has anti-parkinsonian effects in young people with advanced Parkinson’s disease," Dr. Hauser said. But the use of animal cells has to be considered because of practical and ethical concerns that may preclude widespread use of human tissue, he said. The study was funded by Diacrin/Genzyme LLC, Charlestown, Massachusetts.
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