Status:
WITHDRAWN
Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease
Lead Sponsor:
NeuroGeneration
Conditions:
Parkinson's Disease
Eligibility:
All Genders
35-85 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Amyotrophy
- Good general health or stable medical condition well controlled, without contraindications to anesthesia
Exclusion
- 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
- Clinically significant laboratory abnormality
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03309514
Start Date
June 1 2022
End Date
June 30 2024
Last Update
April 12 2022
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