Parkinsonism, Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Neural stem cells
Brief summary
The aim of this study is to develop and optimize methods to isolate, propagate and differentiate adult human neural stem cells from patients with degenerative neurological disorders like Parkinson's disease.
Detailed description
In this project the investigators propose to analyze tissue samples from different nervous system regions obtained during neurosurgical procedures in order investigate the presence of neural stem cells in different cerebral areas. The investigators will also evaluate techniques for neural stem cell cryopreservation, for possible future therapeutic uses. Patients with degenerative neurological disorders like Parkinson's disease undergoing neurosurgical procedures meeting our selection criteria will be candidate for this study.
Interventions
PROCEDUREHarvesting of neural stem cells
During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.
Sponsors
NeuroGeneration
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Able to give informed consent prior to study 2. Male or Female with Diagnostic Criteria of Parkinson's disease or neurodegenerative disorder undergoing a neurosurgical procedure 3. Age 35 to 85 years old 4. Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease 5. Hoehn and Yahr Stage III or IV 6. Parkinson's disease observed in the absence of: * Oculomotor palsy * Cerebellar sign * Orthostatic hypotension (drop greater than 20mmHg in mean pressure) * Pyramidal sign * Amyotrophy 7. Good general health or stable medical condition well controlled, without contraindications to anesthesia
Exclusion criteria
1. Patients with severe dementia and brain atrophy on MRI 2. Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV 3. Patients older than 85 or younger than 35 4. Patients who withhold informed consent 5. Patients with a history of alcohol or drug abuse 6. Sexually active women of childbearing potential without adequate form of birth control 7. Evidence of abnormal coagulation or anticoagulant therapy 8. Pregnancy or lactation 9. History of seizure disorders or current use of antiepileptic medication 10. Severe cognitive impairment 11. Clinically significant laboratory abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuronal differentiation into dopaminergic neurons | 6 months | Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure |
Countries
United States
Outcome results
None listed