Molecular Analysis of Human Neural Stem Cells

Study Overview
=================
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.

Official Title
-----------------
Molecular Analysis of Adult Human-derived Neural Stem Cells

Conditions
-----------------
Parkinson's Disease, Parkinsonism

Intervention / Treatment
-----------------
* Procedure: Harvesting of neural stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neural stem cells<br> | Procedure: Harvesting of neural stem cells<br>* During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuronal differentiation into dopaminergic neurons | Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Neural stem cells