NCT00283023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

January 25, 2006

Last Update Submit

October 14, 2020

Conditions

Demyelinating Diseases

Keywords

All selective craniotomy

Outcome Measures

Primary Outcomes (1)

  • Number of oligodendrocyte progenitor cell differentiation

    one month

Study Arms (1)

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

Oligodendrocyte progenitor cell culture/craniotomyPROCEDURE

Oligodendrocyte progenitor cell culture protocol of Rajavithi Hospital will be apply

Also known as: Rajavithi Oligodendrocyte progenitor cell culture protocol
A

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistant Professor Subsai Kongsaengdao

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Demyelinating Diseases

Interventions

Craniotomy

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Subsai Kongsaengdao, M.D.

    Division of Neurology, Department of Medicine, Rajavithi Hospital : Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Cell culture
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

December 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

TH(1)