Deficient T Regulatory Cell (Treg) Function in Patients With Relapsing Remitting Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT04857489|
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
|Condition or disease|
|Relapse Remitting Multiple Sclerosis|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Deficient T Regulatory Cell (Treg) Function in Patients With Relapsing Remitting Multiple Sclerosis|
|Actual Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Patients with Relapse Remitting Multiple Sclerosis
- Characterize natural (n) Tregs' functional deficit in RRMS [ Time Frame: Baseline ]Functional suppression assays will compare Treg suppressive function in a third cohort of 10 HC and 10 RRMS patients.
- Identify the role of inducible (i) Treg cells in maintaining the immunological tolerance in RRMS [ Time Frame: Baseline ]
- Identify the phenotype changes in CD4+CD25+CD127 nTregs in RRMS patients [ Time Frame: Baseline ]Transcriptional profiling of sorted CD4+CD25+CD127- Tregs will be performed using RNAseq in the first cohort of 10 HCs and 10 RRMS patients.
- Characterize functional deficits of nTregs in RRMS [ Time Frame: Baseline ]Functional suppression assays will compare Treg suppressive function in a third cohort of 10 HC and 10 RRMS patients.
- Determine the effects of hemostatic cytokines on the nTregs' suppressive function in RRMS [ Time Frame: Baseline ]
- Determine the phenotype of iTreg cells in RRMS [ Time Frame: Baseline ]Flow cytometry studies of the IL-10+CD4+ and TGF-B+CD4+ cells derived from RRMS patients and HCs will identify disease-specific phenotype of iTregs, which may reflect functional changes of iTregs in RRMS.
- Identify the mechanisms of deficient nTreg induction of iTregs in RRMS [ Time Frame: Baseline ]We will perform the suppressive assay using CD4+CD25+CD127-Treg and CD4+CD25-CD127+ Teff cells derived from the fourth cohort of 10 HCs and 10 RRMS patients.
- Characterize the effect of the iTreg-produced immunoregulatory cytokines on the reconstitution of immune tolerance [ Time Frame: Baseline ]We will measure the IFN-y, IL-17A, IL-17F, IL-21, IL-22, IL-9, and IL-10, TGF-B and IL-35 levels in the SNs of the above co-cultures of iTregs and CD4+ cell derived from RRMS patients and HCs at 48 h.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857489
|Contact: Silva Markovic-Plese, MD, PhD||215-503-6393||Silva.Markovic-Plese@jefferson.edu|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Silva Markovic-Plese, MD, PhD 215-503-6393 Silva.Markovic-Plese@jefferson.edu|