Fetal Brain Cell Implants Aid Patients - Brief Article

In the first double-blind, placebo-controlled surgical trial testing the safety and effectiveness of fetal dopamine cell implantation for the treatment of Parkinson's disease, many patients who received the implants showed growth of the new brain cells and improvement in their symptoms. Compared to patients who received the placebo operation, transplanted patients were better able to move and perform other activities before taking their daily medications.

There was a great deal of variability in the transplant outcome, so the benefit for any individual patient was unpredictable. When patients were grouped by age, those under 60 benefited, while those over 60 did not. "The results of the placebo-controlled study are critical for guiding our research on improving cell transplantation as a treatment for Parkinson's disease," notes Curt Freed, director of the Division of Clinical Pharmacology and Toxicology, University of Colorado Health Sciences Center, Denver. "We are now testing ways to produce a more uniform response and to understand why older patients are more resistant to the effects of the transplant," he explains.

"While placebo-controlled drug trials have long been the gold standard to test the value of a new drug, only a few placebo-controlled surgical trials have been conducted," indicates Stanley Fahn, director of the Center for Parkinson's Disease and Other Movement Disorders, Columbia Presbyterian Center of New York Presbyterian Hospital. "In Parkinson's disease, about 30% of patients feel better after getting a placebo drug. We found that some patients who had placebo surgery did feel their Parkinson's disease had improved."

Half of the patients had fetal cells implanted in four locations in their brains through a surgical procedure performed under local anesthesia. Patients in the other group had a similar procedure, in which holes were drilled in their skulls without penetrating the brain, and no fetal cells were implanted.

David Eidelberg, director of the North Shore University Hospital's Functional Brain Imaging Laboratory, Manhasset, N.Y., and his team, none of whom knew who had received the transplant, then evaluated the patients using positron-emission tomography (PET) to study the growth of the transplants.

Nineteen women and 21 men were enrolled in the trial. Half of the patients were over 60, and the average duration of disease was 13.8 years. PET scans were conducted prior to surgery and at 12 months after the procedure. Eidelberg detected significant growth of the implanted cells in about two-thirds of the transplant patients and detected some growth in 17 of them. Autopsies of two patients who died of causes unrelated to the transplant operation showed significant growth of the implanted tissue.

After one year of evaluation and data collection, individual patients and their doctors were told which procedure they had received. Those who had the placebo operation were given the choice of receiving the fetal implants. Nearly all placebo patients have decided to have the tissue implant.

Parkinson's, a chronic, neurologic disease that impairs mobility, results from the progressive loss of a small number of nerve cells that produce dopamine. While treatment with drugs such as L-dopa has provided substantial relief for most patients, the medications tend to lose their effectiveness after five years of use. The goal of fetal tissue implants is to replace the lost dopamine-producing cells and restore more normal movement to the patients.

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