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Clinical Trials in France / NCT05424627
Starting soon Observational

Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

NCT05424627 · tracked via the Priya Life Science France tracker
Sponsor
Central Hospital, Nancy, France
Phase
Observational
Started
2022-07-15
Last updated
2022-06-21

Condition(s) studied

Systemic Lupus Erythematosus

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • MDSC percentage among total PBMC — Baseline
    Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
  • MDSC percentage among total PBMC — 3 months
    Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
  • MDSC percentage among total PBMC — 6 months
    Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
  • MDSC percentage among total PBMC — 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)

Trial sites (1)

FacilityCityRegionStatus
Thomas Moulinet Vandœuvre-lès-Nancy Lorraine

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Other trials for the same condition

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus Active, not recruiting
Ferroptosis Role in the Pathophysiology of Systemic Lupus Erythematosus Recruiting
HLA Antibodies in Systemic Lupus Erythematosus Recruiting
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) Active, not recruiting
Follow-up of the Systemic Lupus Erythematosus Cohort as Part of the Multidisciplinary Consultation at Brest CHRU Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05424627 on ClinicalTrials.gov ↗ ← All trials in France