Molecular Analysis of Human Neural Stem Cells

Withdrawn

• Conditions: Parkinson's Disease; Parkinsonism
• Interventions: Procedure: Harvesting of neural stem cells

• Registration Number: NCT01329926
• Lead Sponsor: NeuroGeneration

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.

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.

Study Timeline

• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-06
• Study Start: 2011-06-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neural stem cells	Harvesting of neural stem cells	-

Primary Outcome Measures

Name	Time	Method
Neuronal differentiation into dopaminergic neurons	6 months	Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure

Trial Locations

Locations (1)

Los Angeles Neurosurgical Institute; 🇺🇸 Los Angeles, California, United States