NCT03309514
Withdrawn
Phase 1
Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
NeuroGeneration0 sitesJune 2022
ConditionsParkinson's Disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- NeuroGeneration
- Primary Endpoint
- Motor UPDRS
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients with Parkinson's disease.
Investigators
Michel F. Levesque, MD
Principal Investigator
NeuroGeneration
Eligibility Criteria
Inclusion Criteria
- •Able to give informed consent prior to study
- •Male or Female with Diagnostic Criteria of Parkinson's disease
- •Age 35 to 85 years old
- •Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
- •Hoehn and Yahr Stage III or IV
- •Parkinson's disease observed in the absence of:
- •Oculomotor palsy
- •Cerebellar sign
- •Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
- •Pyramidal sign
Exclusion Criteria
- •Patients with severe dementia and brain atrophy on MRI
- •Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
- •Patients older than 85 or younger than 35
- •Patients who withhold informed consent
- •Patients with a history of alcohol or drug abuse
- •Sexually active women of childbearing potential without adequate form of birth control
- •Evidence of abnormal coagulation or anticoagulant therapy
- •Pregnancy or lactation
- •History of seizure disorders or current use of antiepileptic medication
- •Severe cognitive impairment
Outcomes
Primary Outcomes
Motor UPDRS
Time Frame: 6 months
UPDRS Motor scale
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