Molecular Analysis of Human Neural Stem Cells

NeuroGeneration

Status: Withdrawn

Conditions: Parkinson's Disease; Parkinsonism

Treatments: Procedure: Harvesting of neural stem cells

Study type: Observational

Funder types: Industry

Identifiers

NCT01329926

NGN-9001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Neural stem cells

Treatment:

Procedure: Harvesting of neural stem cells