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PD96-1101: Phase 2, Double-Blind, Randomized, Controlled Multi-Center Clinical Trial of the Safety and Efficacy of Transplanted Fetal Porcine Cells in Patients with Parkinson's Disease
This study has been completed.
Sponsored By:
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Genzyme
Diacrin/Genzyme Corporation LLC
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Information Provided By:
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Genzyme
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ClinicalTrials.gov Identifier:
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NCT00226460
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Purpose
The purpose of this study was to evaluate the differences in safety and efficacy between Parkinson's disease patients who either received transplantation of fetal porcine cells or placebo treatment.
Condition
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Intervention
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Phase
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Parkinson's Disease
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Drug: Fetal porcine cells, Neurocell-PD
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Phase II
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Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Further Study Details:
Primary Outcomes: change in UPDRS
Secondary Outcomes: change in PET scan
Study start: August 1997; Study Completion: January 2001
Eligibility
Ages Eligible for Study: 40 Years - 70 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
 | The patient has idiopathic Parkinson’s disease.
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| with bradykinesia and either rest tremor or rigidity.
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| history of asymmetry of Parkinson’s disease signs,
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| history of progression of Parkinson’s disease signs,
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| no other suspected cause of Parkinson’s disease.
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| the patient is L-DOPA responsive (based on the Treating Investigator’s clinical judgment, the patient demonstrates a predictable ON response after the first daily dose of L-DOPA)
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| The patient has had Parkinson’s disease for at least 5 years (from onset of symptoms).
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| The patient demonstrates unequivocal Clinical Off periods.
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| Patient has been on a stable regimen of L-DOPA and any other anti-Parkinsonian medications for at least one month prior to start of screening.
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| The patient demonstrates L-DOPA-or dopamine agonist-induced dyskinesias.
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| The patient’s age is 40-70.
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| The patient is currently under “optimal medical therapy”, as determined by the Treating Investigator.
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| The patient has had a UPDRS assessment as per a modified CAPIT protocol at screening and the total UPDRS score in the defined OFF state was at least 60.
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| If the patient is a woman of child bearing potential, she must not be nursing and an adequate form of birth control must be used for the duration of this trial.
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| The patient has a normal chest x-ray and does not exhibit any signs or symptoms of coronary artery disease (on exam or on EKG) dysrhythmia (in order for surgery to be safely performed).
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| The patient is able to understand and is willing to comply with study requirements; this may include travel within or outside the United States for neuroimaging testing and surgery. It will be necessary for a companion to travel with the patient.
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| The patient is able to provide written informed consent.
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| The patient understands that the Sponsor recommends that all patients in this trial avoid pregnancy and minimize the sharing of secretions with sexual partners.
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| The patient is willing to participate in the life-long xenotransplantation registry. |
Exclusion Criteria:
| The patient is pregnant or lactating.
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| The patient has received an investigational drug within 30days prior to the study enrollment.
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| The patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly interfere with study compliance including all prescribed evaluations and follow-up activities |
Location Information
Florida
PD and Movement Disorders, University of South Florida, Tampa, Florida, 33606, United States
More Information
Study ID Numbers: PD96-1101
ClinicalTrials.gov Identifier: NCT00226460
Health Authority: United States: Food and Drug Administration
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Contact Information
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
T:617 252 7500
F:617 252 7600
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