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| Tracking Information | |||||
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| First Received Date ICMJE | January 25, 2006 | ||||
| Last Updated Date | August 2, 2008 | ||||
| Start Date ICMJE | December 2007 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of oligodendrocyte progenitor cell differentiation [ Time Frame: one month ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Number of Oligodendrocyte progenitor cells differentiation | ||||
| Change History | Complete list of historical versions of study NCT00283023 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Oligodendrocyte Progenitor Cell Culture From Human Brain | ||||
| Official Title ICMJE | Phase 1: Oligodendrocyte Progenitor Cell Culture From Human Brain | ||||
| 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. |
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| Detailed Description | Oligodendrocyte progenitor cell line were cultures and will be transplanted into the patient with Multiple sclerosis. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Demyelinating Diseases | ||||
| Intervention ICMJE | Procedure: Oligodendrocyte progenitor cell culture/craniotomy | ||||
| Study Arms / Comparison Groups | Experimental: Progenitor cells from the patinets with Craniotomy with V-P Shunt or ventriculostomy will be collected and cultured. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00283023 | ||||
| Responsible Party | Assistant Professor Subsai Kongsaengdao, Rajavithi Hospital | ||||
| Study ID Numbers ICMJE | RH-CMR-003, RVH-CMR-003 grant | ||||
| Study Sponsor ICMJE | Rajavithi Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Rajavithi Hospital | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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