The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS
Neurology Service, Hospital Clinic de barcelona
Barcelona, Barcelona, Spain
To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study
The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI
Time frame: 12 months
To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales
clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis
Time frame: 12 months
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