跳至主要内容
临床试验/NCT05705986
NCT05705986招募中不适用

Immunoregulatory Effect of Microparticle Delivered STING Agonist in the Control of Experimental Autoimmune Encephalomyelitis (EAE) and Multiple Sclerosis (MS)

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Determine the capacity of cGAMP MP-treated DCs to induce iTreg expansion in human in-vitro cultures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Determine the capacity of cGAMP MP-treated DCs to induce iTreg expansion in human in-vitro cultures

时间窗: 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

Characterize cGAMP MP-induced tolerogenic DCs from RRMS patients.

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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