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Molecular Analysis of Human Neural Stem Cells

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Michel F. Levesque, MD, NeuroGeneration
ClinicalTrials.gov Identifier:
NCT01329926
First received: March 31, 2011
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  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
 Phase 0

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:

U.S. FDA Resources

Further study details as provided by NeuroGeneration:

Primary Outcome Measures:
  • Neuronal differentiation into dopaminergic neurons [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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: June 2014 (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

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Michel F. Levesque, MD, Principal Investigator, NeuroGeneration
ClinicalTrials.gov Identifier: NCT01329926     History of Changes
Other Study ID Numbers: NGN-9001
Study First Received: March 31, 2011
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013