Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004844
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
1999-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the putamen of patients with Parkinsons disease
I Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the putamen of patients with Parkinsons disease
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled study Patients are stratified by age over and under 60 Patients are randomized to receive either sham surgery or tissue implantation
Embryonic tissue is prepared While patients are awake but sedated bilateral incisions are made in the skin and burr holes drilled in the skull A cannula is inserted into the brain to the posterior putamen Implant patients receive embryonic neural tissue or sham patients have no needles penetrate the brain After 1 year patients who receive the sham operation in the first operation may receive embryonic neural tissue in a second operation
Patients are followed every 4 months during the first year and every 6 months thereafter
Embryonic tissue is prepared While patients are awake but sedated bilateral incisions are made in the skin and burr holes drilled in the skull A cannula is inserted into the brain to the posterior putamen Implant patients receive embryonic neural tissue or sham patients have no needles penetrate the brain After 1 year patients who receive the sham operation in the first operation may receive embryonic neural tissue in a second operation
Patients are followed every 4 months during the first year and every 6 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCHSC-COMIRB-9397 | None | None | None |