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Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00004844
Collaborator
University of Colorado, Denver (Other)
40
Enrollment

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. 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
  • Procedure: tissue implantation
 N/A

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 1998

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    PROTOCOL ENTRY CRITERIA:

    --Disease Characteristics--

    • Idiopathic Parkinson's disease for at least 7 years with rest tremor or bradykinesia and one of the following cardinal signs: Rigidity Flexed posture Loss of postural reflexes Freezing (motor blocks)

    • Continuing response to levodopa

    • Presence of at least one of the following intractable symptoms or signs: Intractable disabling fluctuations Intractable disabling dyskinesias Intractable "on" freezing (i.e., motor blocks that interfere with walking despite being "on"

    • Bilateral parkinsonism when "off" (may be asymmetry between right and left sides)

    • Decreased dopa uptake in the striatum

    --Prior/Concurrent Therapy--

    • No prior brain surgery

    --Patient Characteristics--

    • Cardiovascular: No severe cardiopulmonary disease

    • Neurologic: No history of strokes No neuroleptics No encephalitis No oculogyric crisis No remission No cerebellar signs No dementia (Mini-Mental state score no greater than

    1. No supranuclear gaze palsy No Babinski sign No orthostatic hypotension No hydrocephalus No brain tumor No occlusive cerebrovascular disease

    • Pulmonary: Absolute standing pressure at least 90/60 mmHg

    • Other: No diabetes mellitus No exposure to toxins No other severe medical disease Hamilton Depression Scale score of less than 20 points

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Institute of Neurological Disorders and Stroke (NINDS)
    • University of Colorado, Denver

    Investigators

    • Study Chair: Curt R. Freed, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004844
    Other Study ID Numbers:
    • 199/13940
    • UCHSC-COMIRB-9397
    First Posted:
    Feb 25, 2000
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jan 1, 1999
    Keywords provided by , ,
    Parkinson Disease
    neurologic and psychiatric disorders
    rare disease
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Jun 24, 2005