- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05705986
Immunoregulatory Effect of Microparticle Delivered STING Agonist in the Control of Experimental Autoimmune Encephalomyelitis (EAE) and Multiple Sclerosis (MS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a lab study only. No medication will be dispensed as a part of the study. No tests or procedures will be performed. Blood ( approximately 10 teaspoons ; 10 green top tubes) will be drawn by a qualified phlebotomist, nurse or physician in the Neurology clinic, during routine clinic visits. Proper medical procedures will be followed when collecting blood to minimize patient risk. In addition, steps will be taken to guard patient's confidentiality. Unique codes will be assigned to each sample. All identifying information will be removed from samples and clinical data before they are given to the research staff conducting the laboratory study. Only the clinic staff will have access to the consent forms, the master list (that connect the unique codes with the patient names) and subject medical records. The blood draw will coincide with the subject's regular visit to the Neurology clinic.
All records will be secured with the current PACS radiology system and computerized information systems/computerized databases which are the current methods for securing all patient information. Care will be taken to preserve the confidentiality of all patient-related information. Material with identifying information will be stored in the clinic locked data storage room. Patient names will not be used in any publications. Results of laboratory studies performed on these samples will not be shared with subjects. Laboratory results will not be incorporated into patients medical records.
The proposal states to separate dendritic cells using magnetic beads separation and use them as an antigen presenting cells to T cells.The therapeutic effect of the nanoparticle delivered phosphatidylserine (PS, PAR-PS) will be measured, using cytokine secretion and the detection of the T regulatory (Treg) cell induction. Proliferation will be determined using CFSE, cytokine secretion will be measured using ELISA and the intracellular cytokine staining for IFNg, IL-17A, IL-17F, IL-21, IL-22, TGFb, IL-10 and IL-4. The induction of Treg cells will be measured using flow cytometry and determining the percentage of CD4+ CD25+ CD127- FoxP3+ Treg cells within the CD4+ lymphocytes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University
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Principal Investigator:
- Silva Markovic-Plese, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterize cGAMP MP-induced tolerogenic DCs from RRMS patients.
Time Frame: Baseline
|
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.
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Baseline
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Determine the capacity of cGAMP MP-treated DCs to induce iTreg expansion in human in-vitro cultures
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the transcriptome of cGAMP MP IL-27- and IL-10-induced Tregs.
Time Frame: Baseline
|
RNA sequencing of iTreg cells after coculture with cGAMP MP-treated (vs.
blank MP-treated) DCs from 10 RRMS patients will detect the differentially expressed genes between cGAM MP- and blank MP-induced iTregs.
The expression of transcription factors identified by RNAseq will be confirmed by RT-PCR and western blot, more quantitative methods.
|
Baseline
|
Determine the in-vitro reconstitution of iTreg suppressive function in RRMS patients after coculture with cGAMP MP-treated DCs.
Time Frame: Baseline
|
Suppression assay will determine to what extent Treg cells from co-cultures with cGAM-MP-treated DCs increase (restore normal) suppressive function in comparison to the co-cultures with blank MP-treated DCs.
|
Baseline
|
Induction of antigen-specific immune tolerance after co-administer DR2-aAPMs with the cGAMP MPs to DCs.
Time Frame: Baseline
|
The suppressive effect of sorted Tregs induced after co-administration of cGAMP MPs and DR2-APM to monocyte-derived DCs, will be tested in co-cultures with autologous T effector cells.
Myelin antigen specificity will be determined in Teff and iTreg cells by MHCII tetramer staining.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Central Nervous System Infections
- Leukoencephalopathies
- Nervous System Autoimmune Disease, Experimental
- Multiple Sclerosis
- Sclerosis
- Encephalomyelitis
- Encephalomyelitis, Autoimmune, Experimental
Other Study ID Numbers
- 20D.098
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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