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

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