Clinical trial NCT05290688: Cellular microRNA Signatures in Multiple Sclerosis
Official title: Cellular microRNA Signatures in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Inflammation
IFN-beta
Autoimmunity
Gene regulation
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Höpital La Pitié-Salpêtrière
First posted: 2022-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 20 untreated RRMS patients divided into 2 groups: 10 RRMS in relapsing phase 10 RRMS in relapse.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: microRNA expression profiles in immune cell populations from RRMS patients
timeFrame: 2 years
Secondary outcomes:
measure: microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients
timeFrame: 2 years
measure: microRNA expression profiles in monocytes from RRMS patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital La Pitié - Salpêtrière
Study officials:
affiliation: Institut Pasteur
name: Frédérique Michel, PhD
role: STUDY_DIRECTOR
References: