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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03796611
Acronym
4BLMS
Enrollment
125
Registered
2019-01-08
Start date
2017-07-24
Completion date
2017-08-24
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

immunology, B cells

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

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

for MS group: * 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 Inclusion Criteria for controls with inflammatory of non inflammatory neurological disease: * patients who signed consent to the study * between 18 and 60 years old patients * naïve of any steroid intake or immune therapy Inclusion criteria for healthy controls: * 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

Design outcomes

Primary

MeasureTime frameDescription
the percentage of 4 BL cells in blood between MS patients and healthy controlsBaseline: one session4 BL are defined using cytometric parameters

Secondary

MeasureTime frameDescription
the percentage of 4 BL cells in blood between MS patients and patients with inflammatory and non inflammatory neurological diseaseBaseline: one session4 BL are defined using cytometric parameters
the percentage of 4 BL cells in CSF between MS patients and patients with inflammatory and non inflammatory neurological diseaseBaseline: one session4 BL are defined using cytometric parameters
to analyse over time the evolution of 4BL percentages in blood in MS patients5 blood collection at baseline, 3, 6, 12, and 24 months after baseline4 BL are defined using cytometric parameters

Countries

France

Contacts

PRINCIPAL_INVESTIGATORHélène ZEPHIR, MD, PhD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026