Autologous Mesenchymal Stem Cells for the Treatment of Neuromyelitis Optica Spectrum Disorders
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|ClinicalTrials.gov Identifier: NCT02249676|
Recruitment Status : Unknown
Verified September 2014 by Fu-Dong Shi, Tianjin Medical University General Hospital.
Recruitment status was: Recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Devic's Syndrome Devic's Neuromyelitis Optica Devic Syndrome Devic's Disease Devic Disease||Biological: Autologous mesenchymal stem cells||Phase 2|
Primary objective was to assess feasibility and safety; the investigators compared adverse events from up to 3months before treatment until up to 12 months after the infusion.
As a secondary objective, the investigators chose efficacy outcomes to assess the Expanded Disability Status (EDSS)、annual relapse rate (ARR) and time to next relapse after transplant.
Third objective anterior visual pathway and pyramidal tract as a model of wider disease. Masked endpoint analyses was used for electrophysiological and selected imaging outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Mesenchymal Stem Cells for the Treatment of Progressive and Refractory Neuromyelitis Optica Spectrum Disorders: an Open-label Phase 2a Proof-of-concept Study|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: Autologous mesenchymal stem cells group
Generated clinical-grade MSC 10 mg chlorpheniramine Po.;100 mg hydrocortisone iv.;10 mg metoclopramide im.;30 min before administration of the cells .
MSC a day-case 2·0×106 cells/kg i.v. 15min Infused normal saline 500 Ml over 4 h i.v.
Biological: Autologous mesenchymal stem cells
Autologous mesenchymal stem cells
Other Name: MSC
Placebo Comparator: Control group
Patients with progressive and refractory NMO treated with regular methods
- EDSS [ Time Frame: change from baseline to one year ]Compare EDSS change before and one year after mesenchymal stem cells (MSC) infusion
- Annual relapse rate [ Time Frame: 1 year after infusion ]Compare annual relapse rate before and one year after MSC infusion
- Lesion load [ Time Frame: 1 year after infusion ]Compared lesion load before and one year after MSC infusion
- Retinal nerve fiber layer (RNFL) [ Time Frame: 1 year after infusion ]Compared RNFL before and one year after MSC infusion
- Cognition [ Time Frame: 1 year after infusion ]Compare cognition questionnaire scale before and one year after MSC infusion
- Immunological assessments [ Time Frame: 1 year after infusion ]Compare anti-aquaporin4-ab before and one year after MSC infusion.
- Immunological assessments [ Time Frame: 1 year after infusion ]Compare immune cell subpopulation before and one year after MSC infusion.
- Immunological assessments [ Time Frame: 1 year after infusion ]Compare cytokine kinetics before and one year after MSC infusion.
- cerebral volume [ Time Frame: 1 year after infusion ]Compare cerebral volume before and one year after MSC infusion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249676
|Contact: Fu-Dong Shi, MD, PhDfirstname.lastname@example.org|
|Tianjin Medical University General Hospital||Recruiting|
|Tianjin, Tianjin, China, 300052|
|Contact: Fu-Dong Shi, MD,PhD 13512041705 email@example.com|
|Principal Investigator: Fu-Dong Shi, MD,PhD|
|Study Chair:||Fu-Dong Shi, MD,PhD||Tianjin Medical University General Hospital|