Molecular Analysis of Human Neural Stem Cells

NCT ID: NCT01329926

Last Updated: 2022-04-12

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease Parkinsonism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Neural stem cells

Harvesting of neural stem cells

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeuroGeneration

INDUSTRY

Sponsor Role lead

Responsible Party

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Michel F. Levesque, MD

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NGN-9001

Identifier Type: -

Identifier Source: org_study_id

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