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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004387
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
National Institute of Neurological Disorders and Stroke (NINDS)
Icahn School of Medicine at Mount Sinai
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


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

Condition or disease Intervention/treatment Phase
Parkinson Disease 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 Type : Interventional  (Clinical Trial)
Enrollment : 34 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 1996

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00004387

Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Neurological Disorders and Stroke (NINDS)
Icahn School of Medicine at Mount Sinai
Study Chair: C. Warren Olanow Icahn School of Medicine at Mount Sinai Identifier: NCT00004387     History of Changes
Other Study ID Numbers: 199/12102
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2000

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases