Molecular Analysis of Human Neural Stem Cells

NCT01329926 | Withdrawn

• 1 other identifier: NGN-9001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Parkinsonism

Keywords

Parkinson's disease; Neural stem cells

Outcome Measures

Primary Outcomes (1)

• Neuronal differentiation into dopaminergic neurons

  Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure

  6 months

Study Arms (1)

Neural stem cells

Procedure: Harvesting of neural stem cells

Interventions

Harvesting of neural stem cells PROCEDURE

During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.

Neural stem cells

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease or parkinsonism

You may qualify if:

• Able to give informed consent prior to study
• Male or Female with Diagnostic Criteria of Parkinson's disease or neurodegenerative disorder undergoing a neurosurgical procedure
• Age 35 to 85 years old
• Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
• Hoehn and Yahr Stage III or IV
• Parkinson's disease observed in the absence of:
• Oculomotor palsy
• Cerebellar sign
• Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
• Pyramidal sign
• Amyotrophy
• Good general health or stable medical condition well controlled, without contraindications to anesthesia

You may not qualify if:

• Patients with severe dementia and brain atrophy on MRI
• Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
• Patients older than 85 or younger than 35
• Patients who withhold informed consent
• Patients with a history of alcohol or drug abuse
• Sexually active women of childbearing potential without adequate form of birth control
• Evidence of abnormal coagulation or anticoagulant therapy
• Pregnancy or lactation
• History of seizure disorders or current use of antiepileptic medication
• Severe cognitive impairment
• Clinically significant laboratory abnormality

Sponsors & Collaborators

• NeuroGeneration: lead

Study Sites (1)

Los Angeles Neurosurgical Institute

Los Angeles, California, 90211, United States

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Brain tissue obtained during neurosurgical procedures yields undifferentiated neural stem cells that are subsequently expanded.

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Michel F Levesque, MD

  Los Angeles Neurosurgical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 6, 2011
• Study Start: June 30, 2011
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

US (1)