Title
Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease
Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
Phase
Phase 1/Phase 2Lead Sponsor
NeuroGenerationStudy Type
InterventionalStatus
WithdrawnIndication/Condition
Parkinson's DiseaseIntervention/Treatment
Intracerebral microinjectionsStudy Participants
0This 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.
Stereotactic delivery of cell suspension into basal ganglia structures
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 Amyotrophy Good general health or stable medical condition well controlled, without contraindications to anesthesia 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 Clinically significant laboratory abnormality