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Mesenchymal Stem Cells in Multiple Sclerosis
NCT02403947Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2015
- Primary completion
- Dec 2017
- Countries
- 1
- Sponsor
- Centre hospitalier universitaire de Toulouse
- Modality
- Stem Cell Therapies
- Conditions
- multiple sclerosis (MS)
01
Overview
Phase 2, randomised, double-blind trial of mesenchymal stem cells in multiple sclerosis (MS) (2 arms), sponsored by Centre hospitalier universitaire de Toulouse. Primary endpoints: Safety of MSCs infusion, number, timeframe of occurrence and severity of Adverse Events at 24 weeks and Number of contrast-enhancing lesions (GEL) at MRI scan at 24 weeks. Started Feb 2015; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
MSC then Placebo
Mesenchymal stem cells at week 0, Placebo at week 24
Placebo then MSC
Placebo at week 0, Mesenchymal stem cells at week 24
03
Who it enrols
Patients with RRMS, SPMS, or PPMS aged 18-50 with disease duration 2-10 years, EDSS 3.0-6.5, and evidence of disease activity or progression despite prior therapy.
04
Endpoints
Primary
Safety of MSCs infusion, number, timeframe of occurrence and severity of Adverse Events
Number of contrast-enhancing lesions (GEL) at MRI scan
Secondary
Efficacy of the experimental treatment in term of combined MRI activity
Efficacy assessed by combined unique MRI activity, volume of GEL, and volume of BH
Number of relapses
Time to sustained progression of disability
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