Lipid Mediators in Multiple Sclerosis

NCT03492606 | Completed

• 1 other identifier: LipidMediators
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a chronic inflammatory neurodegenerative disease associated with uncontrolled inflammation and autoimmunity and for which there is still an unmet need for new diagnostic and therapeutic options, especially for the progressive forms. Recent studies suggest that chronic inflammation can be a consequence of failure to resolve inflammation, the resolution of which is mediated by a newly discovered genus of highly potent anti-inflammatory lipids derived metabolically from omega-3 essential fatty acids and termed specialized pro-resolving lipid mediators (SPMs). Herein, we propose to identify SPMs as leads for the control of MS pathology and progression and to propose them as novel disease-modifying treatments by assessing their ex vivo/in vitro and in vivo role in modulating the balance of effector and regulatory cells and/or the mechanisms leading to chronicity as wells as in promoting activation of anti-inflammatory and neuroprotective pathways.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• SPMs in plasma

  levels of the different members of the family of SPMs in plasma

  2021

• T cells

  analysis of T cells functions

  2021

• EAE

  we will treat acute EAE mice (n=8 per each experimental group) at the peak of the disease (day 16-19) with those SPMs that will result to be the most efficacious in modulating pathogenic T-cell responses

  2021

Study Arms (1)

multiple sclerosis patients

Procedure: Samples

Interventions

Samples PROCEDURE

lumbar puncture, blood and CSF samples, SNPs analysis

multiple sclerosis patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

20 recurrent-remitting patients (RR-MS) and 10 primary-progressive patients (P-MS), according to the MacDonald or Poser method, without any type of treatment and 15 healthy donors of the same age and with no previous history of neurological diseases. Blood samples will be recruited at the IRCCS INM Neuromed, under the supervision of dr. Fabio Buttari who will make the diagnosis. The diagnosis of MS will be performed according to the criteria of MacDonald or Poser. On this occasion, the patient will be offered participation in the study, giving informed consent and explaining in non-technical language, what the research consists of, which parameters will be evaluated and for what purpose. Once consent is obtained from the patients, venous samples will be taken (15 mL).

You may not qualify if:

• Subjects who have at least one of the following characteristics will not be included in the study:
• subjects with CNS or autoimmune diseases
• subjects affected by RR-MS in immunomodulatory treatment
• subjects with RR-MS with monocytosis, infections or fever

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: March 1, 2019
• Primary Completion: September 9, 2020
• Study Completion: January 9, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)