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临床试验/NCT05424627
NCT05424627尚未招募不适用

Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
MDSC percentage among total PBMC

研究概览

简要总结

Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.

The objectives of this study is to assess the involvement of MDSC in SLE through accurate phenotypical and functional assessment, as well as characterizing their immunometabolic profile, and to identify innovative therapeutic strategies.

详细描述

Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.

To gain insight into the involvement of MDSC in SLE, both deep phenotypical characterization of MDSC and functional assessment will be performed, as well as immunometabolic characterization. This data will be correlated to the clinical presentation and activity of SLE.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active systemic lupus erythematosus (SLEDAI > or = 1)
  • Written informed consent

排除标准

  • Chronic or acute infection
  • Other active auto-immune condition
  • Active cancer
  • Age below 18

结局指标

主要结局

MDSC percentage among total PBMC

时间窗: Between 9 and 24 months if patient experience relapse during follow-up

Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)

次要结局

  • MDSC inflammasome activation(Between 9 and 24 months if patient experience relapse during follow-up)
  • MDSC subpopulations percentage(Between 9 and 24 months if patient experience relapse during follow-up)
  • Immunometabolic profile(Between 9 and 24 months if patient experience relapse during follow-up)
  • Serum cytokine levels(Between 9 and 24 months if patient experience relapse during follow-up)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas MOULINET

MD

Central Hospital, Nancy, France

研究点 (1)

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