Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
The study aims at identifying the type of B and CD4 T cell subsets with pathogenic properties in the different clinical forms of multiple sclerosis. This research might open new therapeutic approaches for the treatment of multiple sclerosis particularly progressive MS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
male or female subjects ;
Age ≥ 18 years;
subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome;
patients for which a blood draw and / or lumbar puncture to collect CSF is performed for diagnostic or therapeutic purpose;
Disqualifiers
Pregnant or breastfeeding women,
patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Trial design
Design model
Single group
Treatments tested in this trial
blood sample
Biological/Vaccine28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
cerebro-spinal fluid
Biological/Vaccine1 ml of cerebro-spinal fluid
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: patients with multiple sclerosis or clinically isolated syndromeExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.
Time frame
At inclusion (day 0)Secondary outcomes
1
Quantification of disease activity scores
Expanded Disability Status Scale (EDSS)
Time frame
At inclusion (day 0)2
Quantification of disease activity scores
ambulation test
Time frame
At inclusion (day 0)3
Number of lesions
evaluated by MRI
Time frame
At inclusion (day 0)4
Size of lesions
evaluated by MRI
Time frame
At inclusion (day 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Bordeaux
Lead sponsor
University of Bordeaux
Collaborator
Source ClinicalTrials.gov