Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease
I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||January 1996|
PROTOCOL OUTLINE: This is a placebo controlled, randomized, double blind study. Patients are randomly assigned to 1 of 3 treatment groups. All patients receive 2 separate operations in which the substantia nigra from either 4 fetuses (Group A) or 1 fetus (Group C) is implanted into the striatum of each side.
Group B patients receive 2 separate placebo operations without fetal transplantation.
The second surgical procedure begins approximately 1 week after the first operation.
After 2 years, treatments are compared. If transplant is shown to benefit Parkinson's disease, then patients who received placebo operation will be offered transplant surgery in the final year of the study.
|Study Chair:||C. Warren Olanow||Mount Sinai School of Medicine|