B Cell Differentiation in MS

Multiple Sclerosis Clinical Trial

— ABCD-SEP  

Official title:

Analysis of B Cell Differentiation in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744351
• Other study ID #: 35RC18_8909_ABCD-SEP
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: April 2024
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional study with minimal risks and constraints, prospective, monocentric.

Description:

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the Central Nervous System (CNS) affecting primarily young adults. This disease is the leading cause of non-traumatic disability in this population. MS has long been considered as a T-cell mediated disease. However, the remarkable efficacy of anti-CD20 monoclonal antibodies in this disease has highlighted the major role of B-lymphocytes in the pathophysiology of this disease. Despite many advances made recently in understanding the role of B-lymphocytes in the pathophysiology of MS, the precise involvement of plasma cells and their function at different stages of the disease remains unclear. In this project, the investigators plan to analyze the differentiation abilities of circulating B-lymphocytes in patients with MS. Follicular helper T cells (TFH) play a crucial role in B lymphocyte differentiation. These cells are located within germinal centers in secondary lymphoid organs, and their memory compartment also circulates in the blood. Several circulating TFH subpopulations have recently been defined, with different helping capacities. There is currently very little data on these cells in MS patients. The investigators therefore plan, in a second step, to characterize the phenotype of the different subpopulations of TFH at the periphery, but also in the CSF of MS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Regarding MS patients (remitting or progressive untreated):

• Adult (age greater than or equal to 18 years) of both sexes;
• MS fulfilling the criteria of McDonald 2017;
• Remittent or progressive form;
• No immunomodulatory or immunosuppressive therapy for at least 3 months;
• Free, informed and written consent signed by the patient.

Regarding Clinically Isolated Syndrome:

• Adult (age greater than or equal to 18 years) of both sexes;
• Clinically isolated syndrome suggestive of MS (at least two typical lesions in two different locations);
• Patient receiving a Lumbar Puncture (PL) for diagnostic purposes;
• No immunomodulatory or immunosuppressive therapy for at least 3 months;
• Free, informed and written consent signed by the patient.

Regarding non-MS patients with neurological inflammatory disease:

• Adult (age greater than or equal to 18 years) of both sexes;
• Patient with non-MS neurological inflammatory disease (examples: meningitis, neurolupus, neurosarcoidosis...);
• Patients with PL for diagnostic or surveillance purposes;
• No immunomodulatory or immunosuppressive therapy for at least 3 months;
• Free, informed and written consent signed by the patient.

Regarding healthy volunteers:

• Adult (age greater than or equal to 18 years) of both sexes;
• Free, informed and written consent signed by the volunteer. Exclusion Criteria:

Regarding all patients:

• Pregnancy;
• Breastfeeding;
• Treatment with corticotherapy in the last month;
• Patient not affiliated to social security;
• Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.

Regarding healthy volunteers:

• Pregnancy;
• Breastfeeding;
• Not affiliated to social security;
• Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Biological Samples
Venous sampling that is performed solely for the purpose of research. The total blood volume taken is 80 ml maximum (8 tubes of 10 ml).
• Biological Samples
Eight additional 10 ml tubes of blood and an additional 5 ml CSF tube will be taken from the patient during a sample taken for the patient's usual check-up /follow-up. Inpatients will also be offered stool removal.
• Biological Samples
The patient will be taken 8 additional tubes of 10 ml of blood (during a blood test performed for the usual assessment of the patient) and an additional 5 ml of CSF in a sample taken for the assessment of the patient.
• Biological Samples
Eight additional 10 ml tubes of blood will be taken from the patient during a sample taken for the patient's usual check-up / follow-up. Inpatients will also be offered stool removal

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasmablasts frequency	Frequency of plasmablasts CD38hiCD27hi obtained after 6 days of differentiation of B cells in vitro, analyzed by flow cytometry	At Day 6 after differentiation of B cells