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NCT Number: NCT05424627

Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Moulinet

Vandœuvre-lès-Nancy, Lorraine, 54500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. MDSC percentage among total PBMC

    Time frame: Baseline

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

  2. MDSC percentage among total PBMC

    Time frame: 3 months

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

  3. MDSC percentage among total PBMC

    Time frame: 6 months

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

  4. MDSC percentage among total PBMC

    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)

Secondary outcomes

  1. Serum cytokine levels

    Time frame: Baseline

    pro and anti-inflammatory cytokine levels in serum

  2. Serum cytokine levels

    Time frame: 3 months

    pro and anti-inflammatory cytokine levels in serum

  3. Serum cytokine levels

    Time frame: 6 months

    pro and anti-inflammatory cytokine levels in serum

  4. Serum cytokine levels

    Time frame: Between 9 and 24 months if patient experience relapse during follow-up

    pro and anti-inflammatory cytokine levels in serum

  5. MDSC inflammasome activation

    Time frame: Baseline

    flow cytometry assessment of inflammasome activation within MDSCs

  6. MDSC inflammasome activation

    Time frame: 3 months

    flow cytometry assessment of inflammasome activation within MDSCs

  7. MDSC inflammasome activation

    Time frame: 6 months

    flow cytometry assessment of inflammasome activation within MDSCs

  8. MDSC inflammasome activation

    Time frame: Between 9 and 24 months if patient experience relapse during follow-up

    flow cytometry assessment of inflammasome activation within MDSCs

  9. Immunometabolic profile

    Time frame: Baseline

    flow cytometry assessment of metabolic profile of MDSCs

  10. Immunometabolic profile

    Time frame: 3 months

    flow cytometry assessment of metabolic profile of MDSCs

  11. Immunometabolic profile

    Time frame: 6 months

    flow cytometry assessment of metabolic profile of MDSCs

  12. Immunometabolic profile

    Time frame: Between 9 and 24 months if patient experience relapse during follow-up

    flow cytometry assessment of metabolic profile of MDSCs

  13. MDSC subpopulations percentage

    Time frame: Baseline

    flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC

  14. MDSC subpopulations percentage

    Time frame: 3 months

    flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC

  15. MDSC subpopulations percentage

    Time frame: 6 months

    flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC

  16. MDSC subpopulations percentage

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Moulinet, MD

CONTACT

[email protected]

+33383155304

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

Acronym: MDSC-SLE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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