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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004387
|Study Chair:||C. Warren Olanow||Mount Sinai School of Medicine|