Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS) (4BLMS)
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|ClinicalTrials.gov Identifier: NCT03796611|
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Recent works highlight the B cells involvement in multiple sclerosis (MS) pathology but their role remains poorly understood. It was previously described that activated memory B cells called 4BL due to the increased expression of 4-1BBL, an activation marker, induce pro-inflammatory response by activating T CD8+ lymphocytes. Those 4BL cells are also described in systemic inflammation in 80 years old people explaining the poor efficiency of vaccination in that sub population. Those 4BL cells can also induce anti-tumoral T cell response.
The hypothesize is that 4BL may induce a pathogenic inflammatory response in MS.
|Condition or disease|
the aim to compare the proportion of peripheral (blood) 4 BL cells but also 4-BL cells in cerebro spinal fluid (CSF) in MS compared to healthy controls and to other inflammatory neurological disease but also non inflammatory neurological disease.
For all groups of patients and controls we will collect blood and CSF only once (at diagnosis time for patients).
Blood collect from healthy controls will come from transfusion volunteers and we won't have CSF from them.
For patients from the MS group, the blood collect will be sequential at diagnosis, 3, 6, 12 and 24 months after during the follow up.
In the blood and CSF we will evaluate:
- percentage of 4 BL cells. 4 BL cells are found using cytometric parameters
- capacity of 4 BL cells to induce inflammatory response in vitro: percentage of induced activated TCD8 proliferation after cell culture using extracellular and intracellular cytometric parameters
|Study Type :||Observational|
|Estimated Enrollment :||172 participants|
|Official Title:||Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
multiple sclerosis patient
MS is defined according to McDonald criteria 2017. MS patients included have a disease duration of less than 1 year
other neurological inflammatory disease
autoimmune encephalitis, myasthenia gravis, chronic inflammatory demyelinating polyradiculitis
neurological non inflammatory disease
benign intracranial hypertension, degenerative disorder
transfusion volunteers from transfusion center
- to compare the percentage of 4 BL cells in blood between MS patients and healthy controls [ Time Frame: Baseline: one session ]4 BL are defined using cytometric parameters
- to compare the percentage of 4 BL cells in blood between MS patients and patients with inflammatory and non inflammatory neurological disease [ Time Frame: Baseline: one session ]4 BL are defined using cytometric parameters
- to compare the percentage of 4 BL cells in CSF between MS patients and patients with inflammatory and non inflammatory neurological disease [ Time Frame: Baseline: one session ]4 BL are defined using cytometric parameters
- to analyse over time the evolution of 4BL percentages in blood in MS patients [ Time Frame: 5 blood collection at baseline, 3, 6, 12, and 24 months after baseline ]4 BL are defined using cytometric parameters
- to constitute at Baseline a biological bank with mononuclear cells from all the groups fo that study [ Time Frame: Baseline: one session ]peripheral blood mononuclear cells from MS, non inflammatory neurological and other inflammatory neurological disease groups
Biospecimen Retention: Samples Without DNA
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): NCT03796611
|Contact: Hélène ZEPHIR, MD, PhD||3 20 44 68 46 ext +email@example.com|
|Principal Investigator:||Hélène ZEPHIR, MD, PhD||University Hospital, Lille|