Results from the first randomized, controlled clinical trial of fetal dopamine cell implants for Parkinson's disease show that the surgery helped a small number of Parkinson's patients, but not all who underwent the experimental therapy. These results raise important questions in the search for improved treatments for Parkinson's disease.
The study, led by Curt Freed, M.D., at the University of Colorado in Denver, and Stanley Fahn, M.D., at Columbia-Presbyterian Medical Center in New York, included 40 patients with advanced Parkinson's disease. Half the patients received the cell implants, while half had a placebo surgery which appeared very similar to the implant procedure. The results will be announced today at the 51st annual meeting of the American Academy of Neurology in Toronto. The study was funded by the National Institute of Neurological Disorders and Stroke (NINDS).
The 40 patients in this study were randomly selected to receive either the cell therapy or the placebo. Patients in the implant group received injections of dopamine-producing cells into the putamen, the area of the brain in which progressive loss of dopamine production triggers the symptoms of Parkinson's disease. Patients given the placebo surgery received four small cosmetic holes in the skull that looked like those made for the implant therapy but which did not penetrate the brain or its tough protective membrane, called the dura. All patients were informed of the risks of the surgery and the possibility that they might initially be in the non-therapeutic placebo group. The patients were evaluated periodically for 1 year after the procedure before they learned whether or not they had received the cell implant therapy. Those originally in the placebo group were then given the opportunity to receive the cell transplants.
After 1 year, the treated patients under age 60 (9 of the total patients in the
trial) showed significant improvements in movement. Patients over ag
Contact: Marian Emr or Margo Warren
301-496-5924 or 5751
NIH/National Institute of Neurological Disorders and Stroke