Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)

• Conditions: Multiple Sclerosis

• Registration Number: NCT03796611
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

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 it 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 Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Study Start: 2020-12
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

Not provided

Exclusion Criteria

• pregnancy or breast-feeding
• patients or controls unable to sign the consent or to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the percentage of 4 BL cells in blood between MS patients and healthy controls	Baseline: one session	4 BL are defined using cytometric parameters

Secondary Outcome Measures

Name	Time	Method
the percentage of 4 BL cells in CSF between MS patients and patients with inflammatory and non inflammatory neurological disease	Baseline: one session	4 BL are defined using cytometric parameters
the percentage of 4 BL cells in blood between MS patients and patients with inflammatory and non inflammatory neurological disease	Baseline: one session	4 BL are defined using cytometric parameters
to analyse over time the evolution of 4BL percentages in blood in MS patients	5 blood collection at baseline, 3, 6, 12, and 24 months after baseline	4 BL are defined using cytometric parameters