Molecular Analysis of Human Neural Stem Cells | NCT01329926

Studies
Molecular Analysis of Human Neural Stem Cells

NCT01329926

Sponsor

NeuroGeneration

Status

Withdrawn

Last Update Posted

Apr 12, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Parkinson's Disease
Parkinsonism

Interventions

Harvesting of neural stem cells

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient funding

Expanded Access Info

Start Date

Jun 30, 2011

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Mar 31, 2011

First Submission Date that Met QC Criteria

Apr 4, 2011

First Posted Date

Apr 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2022

Last Update Posted Date

Apr 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Label	Type	Description	Intervention Names
Neural stem cells			Procedure: Harvesting of neural stem cells

Name	Type	Description	Arm Group Labels	Other Names
Harvesting of neural stem cells	Procedure	During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Parkinson's disease or parkinsonism

Sampling Method

Non-Probability Sample

ID	Term
D010300	Parkinson Disease
D020734	Parkinsonian Disorders

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases