Oligodendrocyte Progenitor Cell Culture From Human Brain | NCT00283023

Studies
Oligodendrocyte Progenitor Cell Culture From Human Brain

NCT00283023

Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Status

Completed

Last Update Posted

Oct 19, 2020Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Demyelinating Diseases

Interventions

Oligodendrocyte progenitor cell culture/craniotomy

Countries

Thailand

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

ID	Type	Description	Link
RVH-CMR-003 grant

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007Actual

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jan 25, 2006

First Submission Date that Met QC Criteria

Jan 26, 2006

First Posted Date

Jan 27, 2006Estimated

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

Oct 14, 2020

Last Update Posted Date

Oct 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Department of Medical Services Ministry of Public Health of ThailandOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Recent developments in the understanding of stem- and progenitor cell differentiation raises hopes that brain damage in chronic neurological diseases may become repaired by systemic or focal transplantation of such cells. Clinical trials of stem- or progenitor cell transplantation in multiple sclerosis are currently premature. The researchers developed a protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment of demyelinating disease.

Detailed Description

Oligodendrocyte progenitor cell line were cultures and will be transplanted into the patient with Multiple sclerosis.

Design Module

Study Type

Interventional

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Progenitor cells from the patinets with Craniotomy with V-P Shunt or ventriculostomy will be collected and cultured.	Procedure: Oligodendrocyte progenitor cell culture/craniotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oligodendrocyte progenitor cell culture/craniotomy	Procedure	Oligodendrocyte progenitor cell culture protocol of Rajavithi Hospital will be apply	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of oligodendrocyte progenitor cell differentiation		one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 20-65 years of age
Informed consent
Has elective craniotomy surgery

Exclusion Criteria:

HIV, hepatitis, and other central nervous system (CNS) infections
Dementia, Alzheimer disease, and neurodegenerative disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Subsai Kongsaengdao, M.D.	Division of Neurology, Department of Medicine, Rajavithi Hospital : Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistant Professor Subsai Kongsaengdao		Bangkok		10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D003711	Demyelinating Diseases

Ancestor Terms

ID	Term
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003399	Craniotomy

Ancestor Terms

ID	Term
D019635	Neurosurgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided