Trials / Completed
CompletedNCT00004387
Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
OBJECTIVES: I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | fetal nigral transplantation |
Timeline
- Start date
- 1996-01-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004387. Inclusion in this directory is not an endorsement.