Thomas Moulinet
Vandœuvre-lès-Nancy, Lorraine, 54500, France
NCT Number: NCT05424627
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.
Trial opening soon.
Get Notified18 year–99 year
All sexes
Observational
Vandœuvre-lès-Nancy, Lorraine, 54500, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
Time frame: 3 months
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
Time frame: 6 months
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
Time frame: 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)
Time frame: Baseline
pro and anti-inflammatory cytokine levels in serum
Time frame: 3 months
pro and anti-inflammatory cytokine levels in serum
Time frame: 6 months
pro and anti-inflammatory cytokine levels in serum
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
pro and anti-inflammatory cytokine levels in serum
Time frame: Baseline
flow cytometry assessment of inflammasome activation within MDSCs
Time frame: 3 months
flow cytometry assessment of inflammasome activation within MDSCs
Time frame: 6 months
flow cytometry assessment of inflammasome activation within MDSCs
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
flow cytometry assessment of inflammasome activation within MDSCs
Time frame: Baseline
flow cytometry assessment of metabolic profile of MDSCs
Time frame: 3 months
flow cytometry assessment of metabolic profile of MDSCs
Time frame: 6 months
flow cytometry assessment of metabolic profile of MDSCs
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
flow cytometry assessment of metabolic profile of MDSCs
Time frame: Baseline
flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC
Time frame: 3 months
flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC
Time frame: 6 months
flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC
Contact information is provided by the study sponsor or research team.
Central Hospital, Nancy, France
Other
Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus
Acronym: MDSC-SLE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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