Cellular microRNA Signatures in Multiple Sclerosis (SEP-MIR)

Pasteur Institute

Status: Not yet enrolling

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Genetic: 50 ml blodd sampling

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05290688

2021-A02983-3 (Other Identifier)

2021-044

Details and patient eligibility

About

A limited number of studies on microRNA expression variation in immune cells have been reported in relapsing-remitting multiple sclerosis (RRMS). These studies have been performed mostly on a small scale and on whole blood mononuclear cells (PBMC).

In a number of cases, RRMS progresses to a severe secondary neurodegenerative form. In this context, it is important to look for biomarkers that could indicate the pathogenic activity of certain immune cell subpopulations.

Full description

SEP-MIR is a prospective, single-center, descriptive study.

Participants will be recruited among adult patients with RRMS coming for a follow-up consultation in the Neurology Department, Nervous System Diseases Pole, at the hôpital Pitié - Salpêtrière (Paris).

As this is a descriptive study, the recruitment of 20 participants (10 patients with relapsing-remitting MS and 10 patients with relapsing-remitting MS) should meet the objectives of this study.

A 50 ml blood sample will be obtained from each participant and several clinical data regarding their pathology will be collected.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Caucasian population
• Female and male individuals with an f/m ratio of 2-4/1
• Individuals with RRMS according to the 2010 McDonald criteria for less than 15 years, with EDSS 1-6, in remission or relapse
• Participant's condition compatible with a maximum of 50 ml of blood collection
• Persons affiliated with a social security plan.

Exclusion criteria

• MS treatment with steroidal anti-inflammatory drugs, immunomodulators or immunosuppressants within 2 months prior to blood collection
• Persons with acute and chronic infectious disease, autoimmune/inflammatory disease or cancer other than MS
• Pregnant or lactating women
• Be under guardianship,
• Be deprived of liberty by judicial or administrative decision, or be under legal protection.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Untreated RRMS patients

Other group

Description:

Untreated RRMS patients with a 50 ml blood sample during their routine care

Treatment:

Genetic: 50 ml blodd sampling