Recruiting

IL-11

Sponsor:

Thomas Jefferson University

Code:

NCT03735823

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

No intervention, just collect blood samples and CSF samples

Study Details

Brief summary:

Since the last submission, the investigator have further characterized the potential of IL--11 to induce encephalitogenic CD4+IL--17A+, IL--21+ and GM--CSF+ cells, which upon passive transfer induced severe RREAE with IL--17A+CCR6+ CD4+ cell, neutrophil, CD8+ and B--cell accumulation within the CNS (manuscript submitted for publication). These findings confirmed our hypothesis and further characterization of the IL--11--induced encephalitogenic CD4+ cells will be performed as planned in the grant proposal

Conditions

Multiple Sclerosis

Study ID

NCT03735823

Start date

Jun 1, 2018

Status verified date

Jun, 2022

Completion date

May 31, 2023

Anticipated

Primary completion date

May 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

First clinical presentation and at least two central nervous system MRI lesions consistent with demyelinating disease;

Age 18-65 inclusive;

Extended disability status score (EDSS) 1.5-5.5;

No immunomodulatory or immunosuppresive therapy prior to the enrollment in the study.

Exclusion Criteria:

Concomitant infection;

Significant medical and psychiatric condition at the disgression of principal investigator;

Pregnant women;

Children and patients participating in research trials will not be enrolled in this study.

Study Design

Enrollment

96 participants

Anticipated

Interventions and Outcome Measures

Interventions

No intervention, just collect blood samples and CSF samples

No intervention

Primary outcome measure

  • Adhesion marker expression of IL-11 producing CD4 T cells in the CNS and peripheral [ Time Frame: baseline ]
  • Cytokine receptor expression of IL-11 producing CD4 T cells in the CNS and peripheral [ Time Frame: baseline ]
  • Chemokine receptor expression of IL-11 producing CD4 T cells in the CNS and peripheral [ Time Frame: baseline ]
  • transcription factor expression of IL-11 producing CD4 T cells in the CNS and peripheral [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Silva Markovic-Plese, MD PhD

215-955-6871silva.markovic-plese@jefferson.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19446

Contacts

Silva Markovic-Plese, MD PhD

215-955-6871silva.Markovic-Plese@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jun 6, 2022

Last verified

Jun, 2022

Keywords

  • IL-11 T cell migration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2022-06-06.