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

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
National Institute of Neurological Disorders and Stroke (NINDS)
Mount Sinai School of Medicine
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004387
  Purpose

OBJECTIVES:

I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.


Condition Intervention Phase
Parkinson Disease
Procedure: fetal nigral transplantation
Phase II

Genetics Home Reference related topics:   familial paroxysmal nonkinesigenic dyskinesia    Parkinson disease   

MedlinePlus related topics:   Parkinson's Disease   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:   34
Study Start Date:   January 1996

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.

  Eligibility
Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004387

Sponsors and Collaborators

Investigators
Study Chair:     C. Warren Olanow     Mount Sinai School of Medicine    
  More Information


Study ID Numbers:   199/12102, MTS-94339, MTS-GCO-94-339
First Received:   October 18, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004387
Health Authority:   United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
Parkinson disease  
neurologic and psychiatric disorders  
rare disease  

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Mental Disorders
Parkinson Disease
Basal Ganglia Diseases
Rare Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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