Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus
Overview
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.
Detailed description
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.
Primary outcome measures
- MDSC percentage among total PBMC [Time frame: Baseline]
- MDSC percentage among total PBMC [Time frame: 3 months]
- MDSC percentage among total PBMC [Time frame: 6 months]
- MDSC percentage among total PBMC [Time frame: Between 9 and 24 months if patient experience relapse during follow-up]
Secondary outcome measures (12)
- Serum cytokine levels [Time frame: Baseline]
- Serum cytokine levels [Time frame: 3 months]
- Serum cytokine levels [Time frame: 6 months]
- Serum cytokine levels [Time frame: Between 9 and 24 months if patient experience relapse during follow-up]
- MDSC inflammasome activation [Time frame: Baseline]
- MDSC inflammasome activation [Time frame: 3 months]
- MDSC inflammasome activation [Time frame: 6 months]
- MDSC inflammasome activation [Time frame: Between 9 and 24 months if patient experience relapse during follow-up]
- Immunometabolic profile [Time frame: Baseline]
- Immunometabolic profile [Time frame: 3 months]
- Immunometabolic profile [Time frame: 6 months]
- Immunometabolic profile [Time frame: Between 9 and 24 months if patient experience relapse during follow-up]
Eligibility criteria
Inclusion criteria
- Active systemic lupus erythematosus (SLEDAI > or = 1)
- Written informed consent
Exclusion criteria
- Chronic or acute infection
- Other active auto-immune condition
- Active cancer
- Age below 18
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Thomas Moulinet — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT05424627 · 2022-A00601-42