Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004387
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinsons Disease
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Determine the effectiveness of fetal nigral transplantation in patients with Parkinsons disease
I Determine the effectiveness of fetal nigral transplantation in patients with Parkinsons 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 Parkinsons disease then patients who received placebo operation will be offered transplant surgery in the final year of the study
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 Parkinsons disease then patients who received placebo operation will be offered transplant surgery in the final year of the study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MTS-94339 | None | None | None |
| MTS-GCO-94-339 | None | None | None |