Molecular Analysis of Human Neural Stem Cells

Parkinson's Disease Clinical Trial

Official title:

Molecular Analysis of Adult Human-derived Neural Stem Cells

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01329926
• Other study ID #: NGN-9001
• Status: Withdrawn
• Start date: June 30, 2011
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: NeuroGeneration
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Disorders
• Parkinsonism

Intervention

Procedure:
• Harvesting of neural stem cells
During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.

Locations

Country	Name	City	State
United States	Los Angeles Neurosurgical Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
NeuroGeneration

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuronal differentiation into dopaminergic neurons	Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure	6 months