Embryonic Dopamine Cell Implants for Parkinson's Disease

Phase 3

Completed

• Conditions: Parkinson Disease
• Interventions: Procedure: embryonic dopamine cell implant surgery; Procedure: placebo

• Registration Number: NCT00038116
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The purpose of this trial is to determine if patients who received embryonic dopamine cell implant surgery showed significantly greater improvement in their Parkinson's disease than a control group undergoing the placebo treatment, and to determine if the cell implant surgery was more effective in younger or older patients.

Detailed Description

Parkinson's disease is caused by the death of a small number of nerve cells that produce a critical chemical called dopamine. The drug L-dopa can partially make up for the lack of dopamine. As time goes on, however, most patients notice that the drugs do not work as well. Oftentimes, patients develop great fluctuations in motor control. Off drugs they cannot move, and on drugs they have excess, exaggerated movements. Research in animals over the last 20 years has shown that dopamine cells can be replaced by transplants of new cells obtained from fetal brain tissue. For the past 14 years, several laboratories around the world have been performing similar transplants of human fetal brain tissue on patients with Parkinson's disease. So far, it has been impossible to compare results from the different groups because no two centers are performing transplants in the same way.

This study seeks to get around that problem using a controlled clinical trial that compares the embryonic dopamine cell implant surgery with a placebo treatment. A total of 40 patients were recruited--half received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants. At present, this study is providing long-term follow-up evaluation and treatment for the subjects.

Study Timeline

• Study Start: 1995-05
• Study First Submitted: 2002-05-29
• Study First Submitted QC: 2002-05-29
• Study First Posted: 2002-05-30
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-03
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
embryonic dopamine cell implant surgery	embryonic dopamine cell implant surgery	embryonic dopamine cell implant surgery
sham surgery	placebo	sham surgery (placebo)

Primary Outcome Measures

Name	Time	Method
a subjective Global Rating Scale	duration of the trial

Secondary Outcome Measures

Name	Time	Method
objective measurements of PD, including UPDRS motor "off", Schwab and England "off", and 19F-fluorodopa uptake	duration of the trial

Trial Locations

Locations (3)

University Hospital, the University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

The Movement Disorder Center, Columbia-Presbyterian Hospital; 🇺🇸 New York, New York, United States