Immunoregulatory Effect of Microparticle Delivered STING Agonist in the Control of Experimental Autoimmune Encephalomyelitis (EAE) and Multiple Sclerosis (MS)
1 other identifier
observational
40
1 country
1
Brief Summary
Microparticles (MPs) as a mode of therapeutic delivery can selectively deliver immunomodulatory treatment to the phagocytic cells, particularly dendritic cells (DCs), inducing their tolerogenic phenotype and function and T regulatory (Treg) cell expansion. The study will characterize the in vitro response of cGAMP immunomodulator incapsulated microparticles on the capacity of DCs and Tregs to regulate the inflammatory response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2021
CompletedFirst Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedJanuary 31, 2023
January 1, 2023
3.2 years
April 20, 2021
January 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Characterize cGAMP MP-induced tolerogenic DCs from RRMS patients.
Flow cytometry study will measure the cGAMP MP phagocytosis by PBMCs and characterize the phenotype of cGAMP MP-induced DCs of 40 untreated RRMS patients after incubation with fluorescently-labelled cGAMP MPs.
Baseline
Determine the capacity of cGAMP MP-treated DCs to induce iTreg expansion in human in-vitro cultures
Flow cytometry studies will characterize the induced Treg phenotype generated after co-culture with cGAMP MP-treated DCs cells to determine the capacity of the cGAMP MP-treated DCs to induce differentiation and expansion of iTregs
Baseline
Secondary Outcomes (3)
Determine the transcriptome of cGAMP MP IL-27- and IL-10-induced Tregs.
Baseline
Determine the in-vitro reconstitution of iTreg suppressive function in RRMS patients after coculture with cGAMP MP-treated DCs.
Baseline
Induction of antigen-specific immune tolerance after co-administer DR2-aAPMs with the cGAMP MPs to DCs.
Baseline
Interventions
Single blood draw
Eligibility Criteria
40 patients diagnosed with relapse remitting multiple sclerosis
You may qualify if:
- Subjects meeting diagnostic criteria for relapsing remitting multiple sclerosis
- Between the ages of 18-55
- Not treated with immunomodulatory therapy, no other neurological diagnosis, no other inflammatory disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Biospecimen
Blood samples
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2021
First Posted
January 31, 2023
Study Start
February 26, 2021
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
January 31, 2023
Record last verified: 2023-01