Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

NCT05424627 | Not Yet Recruiting

• 1 other identifier: 2022-A00601-42
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

myeloid derived suppressor cells

Outcome Measures

Primary Outcomes (4)

• MDSC percentage among total PBMC

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

  Baseline

• MDSC percentage among total PBMC

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

  3 months

• MDSC percentage among total PBMC

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

  6 months

• MDSC percentage among total PBMC

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

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

Secondary Outcomes (16)

• Serum cytokine levels

  Baseline

• Serum cytokine levels

  3 months

• Serum cytokine levels

  6 months

• Serum cytokine levels

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

• MDSC inflammasome activation

  Baseline

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with active SLE

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Thomas Moulinet

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of peripheral blood mononuclear cells for functionnal and flow cytometry analysis. Collection of serum for cytokine level assessment.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Thomas Moulinet

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Moulinet, MD

CONTACT

+33383155304; t.moulinet@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: July 15, 2022
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)