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OpenTrials
Completed

NCT Number: NCT03744351

B Cell Differentiation in MS

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological Samples

Other

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).

Primary outcomes

  1. Plasmablasts frequency

    Time frame: At Day 6 after differentiation of B cells

    Frequency of plasmablasts CD38hiCD27hi obtained after 6 days of differentiation of B cells in vitro, analyzed by flow cytometry

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Analysis of B Cell Differentiation in Multiple Sclerosis

Acronym: ABCD-SEP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2018
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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