The purpose of this study is to assess the safety and the preliminary efficacy of a single infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple Sclerosis. The study duration for the patients (from start of baseline to end of follow-up) is 270 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
1 administration comprising 5 - 50 millions of cells
Cliniques universitaires Saint-Luc
Brussels, Belgium
University Hospital Leuven (Gasthuisberg)
Leuven, Belgium
University Hospital of Liège
Liège, Belgium
Safety of the cell based immunotherapy (Adverse events)
Adverse events
Time frame: 6 months
Safety of the cell based immunotherapy (Vital signs)
Vital signs
Time frame: 6 hours
Safety of the cell based immunotherapy (Physical examination)
Physical examination
Time frame: 6 months
Safety of the cell based immunotherapy (Laboratory parameters)
Laboratory parameters
Time frame: 6 months
Safety of the cell based immunotherapy (MRI)
MRI
Time frame: 6 months
MRI derived parameters
* Cumulative number and mean number per scan of active inflammatory lesions * Cumulative number and mean number per scan of new lesions * Cumulative number and mean number per scan of enlarged lesions
Time frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration
Expanded Disability Status Scale (EDSS)
Time frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration
Clinical relapses
Time frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration
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Circulating MOG specific cytolytic CD4+ cells
Time frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration
Circulating anti-MOG antibodies
Time frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration