Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00004844|
Recruitment Status : Unknown
Verified January 1999 by Office of Rare Diseases (ORD).
Recruitment status was: Active, not recruiting
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
I. Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the putamen of patients with Parkinson's disease.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Procedure: tissue implantation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Study Start Date :||July 1998|
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): NCT00004844
|Study Chair:||Curt R. Freed||University of Colorado, Denver|