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Molecular Analysis of Human Neural Stem Cells

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329926
First Posted: April 6, 2011
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michel F. Levesque, MD, NeuroGeneration
  Purpose
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.

Condition Intervention Phase
Parkinson's Disease Parkinsonism Procedure: Harvesting of neural stem cells Early Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Analysis of Adult Human-derived Neural Stem Cells

Resource links provided by NLM:


Further study details as provided by Michel F. Levesque, MD, NeuroGeneration:

Primary Outcome Measures:
  • Neuronal differentiation into dopaminergic neurons [ Time Frame: 6 months ]
    Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure


Biospecimen Retention:   Samples With DNA
Brain tissue obtained during neurosurgical procedures yields undifferentiated neural stem cells that are subsequently expanded.

Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Neural stem cells Procedure: Harvesting of neural stem cells
During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease or parkinsonism
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329926


Locations
United States, California
Los Angeles Neurosurgical Institute
Los Angeles, California, United States, 90211
Sponsors and Collaborators
NeuroGeneration
Investigators
Principal Investigator: Michel F Levesque, MD Los Angeles Neurosurgical Institute
  More Information

Additional Information:
Responsible Party: Michel F. Levesque, MD, Principal Investigator, NeuroGeneration
ClinicalTrials.gov Identifier: NCT01329926     History of Changes
Other Study ID Numbers: NGN-9001
First Submitted: March 31, 2011
First Posted: April 6, 2011
Last Update Posted: December 5, 2016
Last Verified: December 2016

Keywords provided by Michel F. Levesque, MD, NeuroGeneration:
Parkinson's disease
Neural stem cells

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases