Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004387|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Procedure: fetal nigral transplantation||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Study Start Date :||January 1996|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004387
|Study Chair:||C. Warren Olanow||Icahn School of Medicine at Mount Sinai|