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

NCT ID: NCT03796611

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2022-10-31

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

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

multiple sclerosis patient

MS is defined according to McDonald criteria 2017. MS patients included have a disease duration of less than 1 year

No interventions assigned to this group

other neurological inflammatory disease

autoimmune encephalitis, myasthenia gravis, chronic inflammatory demyelinating polyradiculitis

No interventions assigned to this group

neurological non inflammatory disease

benign intracranial hypertension, degenerative disorder

No interventions assigned to this group

healthy controls

transfusion volunteers from transfusion center

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• MS defined by McDonald 2017 criteria with a disease duration of less than 1 year
• between 18 and 60 years old patients
• naïve of any immune therapy or steroid intake
• patients who signed consent to the study

• patients who signed consent to the study
• between 18 and 60 years old patients
• naïve of any steroid intake or immune therapy

• control who signed consent at transfusion center for their blood collect to be used for study
• between 18 and 60 years old patients
• naïve of any steroid intake or immune therapy

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélène ZEPHIR, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

Hélène ZEPHIR, MD, PhD

Role: CONTACT

helene.zephir@chru-lille.fr

3 20 44 68 46 ext. +33

Other Identifiers

2017-A00835-48

Identifier Type: OTHER

Identifier Source: secondary_id

2016_04

Identifier Type: -

Identifier Source: org_study_id