Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2011-06-30
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Neural stem cells
Harvesting of neural stem cells
During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.
Interventions
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Harvesting of neural stem cells
During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.
Eligibility Criteria
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Inclusion Criteria
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
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
35 Years
85 Years
ALL
No
Sponsors
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NeuroGeneration
INDUSTRY
Responsible Party
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Michel F. Levesque, MD
Principal Investigator
Principal Investigators
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Michel F Levesque, MD
Role: PRINCIPAL_INVESTIGATOR
Los Angeles Neurosurgical Institute
Locations
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Los Angeles Neurosurgical Institute
Los Angeles, California, United States
Countries
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Related Links
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Related Info
Other Identifiers
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NGN-9001
Identifier Type: -
Identifier Source: org_study_id
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