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Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00004387
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH), Icahn School of Medicine at Mount Sinai (Other)
34
Enrollment

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.
Condition or Disease Intervention/Treatment Phase
  • Procedure: fetal nigral transplantation
 Phase 2

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 Parkinson's disease, then patients who received placebo operation will be offered transplant surgery in the final year of the study.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 1996

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    --Disease Characteristics-- Advanced Parkinson's disease Hoehn-Yahr stage IV or worse during "off" periods Hoehn-Yahr stage III or better during "on" periods Predictable motor fluctuations with at least 20% of waking day in the "off" stage No atypical parkinsonism or secondary parkinsonism --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable doses of levodopa/carbidopa or any other antiparkinson therapy for 2 months prior to study Surgery: No previous intracranial/neurosurgical procedures --Patient Characteristics-- Renal: Creatinine clearance at least 70 mL/min or creatinine no greater than 1.8 mg/dL Protein no greater than 300 mg/dL Other: Not pregnant or nursing Adequate contraception required of fertile patients Prior history of good response to levodopa No sensitivity to cyclosporine Not HIV positive (e.g., HIV I or II) No human T-cell leukemia/lymphoma virus (HTLV-1) No tremors interfering with stereotactic surgery No clinically significant medical, neoplastic or infectious disease No clinically significant laboratory abnormality No dementia that precludes signing informed consent or score of less than 24 on Mini-Mental status examination

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)
    • National Institute of Neurological Disorders and Stroke (NINDS)
    • Icahn School of Medicine at Mount Sinai

    Investigators

    • Study Chair: C. Warren Olanow, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004387
    Other Study ID Numbers:
    • 199/12102
    • MTS-94339
    • MTS-GCO-94-339
    First Posted:
    Oct 19, 1999
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jul 1, 2000
    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