Cellular microRNA Signatures in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— SEP-MIR  

Official title:

Cellular microRNA Signatures in Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05290688
• Other study ID #: 2021-044
• Secondary ID: 2021-A02983-3
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: September 15, 2024

Study information

• Verified date: August 2022
• Source: Institut Pasteur
• Contact: Frédérique Michel, PhD
• Phone: +33 1 45 68 86 38
• Email: frederique.michel[@]pasteur.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Genetic:
• 50 ml blodd sampling
50 ml blood sampling for genetic analysis (expression profiles of microRNAs)

Locations

Country	Name	City	State
France	Hôpital La Pitié - Salpêtrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur	Höpital La Pitié-Salpêtrière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microRNA expression profiles in immune cell populations from RRMS patients	RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients	2 years
Secondary	microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients	RNAseq and/or Nanostring sequencing of unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients	2 years
Secondary	microRNA expression profiles in monocytes from RRMS patients	RNAseq and/or Nanostring sequencing of monocytes from RRMS patients	2 years