Using stem cells from umbilical cords to treat severe kidney lupus

Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus

This study is testing if stem cells from umbilical cords can help people with severe kidney problems caused by lupus feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Universidad de los Andes, Chile (other)
• Drugs / interventions: Cyclophosphamide
• Locations: 2 sites (Santiago de Chile, Región Metropolitana and 1 other locations)
• Trial ID: NCT03917797 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the effectiveness and dose-response of umbilical cord-derived mesenchymal stromal cells (MSCs) in patients with severe renal systemic lupus erythematosus (SLE). The trial consists of an initial phase with escalating doses of MSCs administered intravenously, followed by a triple-blind, controlled phase comparing the selected MSC dose to a placebo. Participants will also receive standard care for their severe renal disease, allowing for a comprehensive assessment of MSC efficacy in this challenging condition.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with systemic lupus erythematosus who have active renal disease and meet specific clinical criteria.

Not a fit: Patients with severely impaired kidney function or those who have recently received certain immunosuppressive treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and overall health outcomes for patients with severe renal lupus.

How similar studies have performed: While the use of MSCs in other conditions has shown promise, this specific application in severe renal lupus is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Fulfilling 1997 updated American College of Rheumatology (ACR) Criteria or 2012 SLICC Classification Criteria for SLE
* Seropositive for antinuclear (≥1:80) and/or anti-DNA antibodies
* Fulfilling following criteria for active renal disease:

Class III or IV proliferative disease (ISN/RPS) Renal Biopsy within 12 months plus...

Active Urinary Sediment (\> 5 red blood cells/high-power field and/or \>8 white blood cells/high-power field and/or cylindruria during the current flare).

UPC ratio ≥ 1

Exclusion Criteria:

* Estimated GFR \< 40ml/min/m2
* Addition during prior 3 months of randomization of: Bolus methylprednisolone or new immunosuppressive drug or intravenous immunoglobulin (IVIG) or Plasmapheresis.
* Addition during prior 6 months of randomization of Cyclophosphamide
* Addition during prior 12 months of randomization of Biological anti-B cell therapy
* Coexisting uncontrolled morbidity; Pregnancy or planned Pregnancy within next 12 months; uncontrolled infection or neoplastic disease. Pending unresolved surgical indication.

Where this trial is running

Santiago de Chile, Región Metropolitana and 1 other locations

• Clínica Universidad de los Andes — Santiago de Chile, Región Metropolitana, Chile (RECRUITING)
• Hospital Barros Luco Trudeau — Santiago de Chile, Región Metropolitana, Chile (RECRUITING)

Study contacts

• Principal investigator: Fernando F E, MD — Professor School of Medicine
• Study coordinator: Fernando F E, MD

Conditions: Lupus Erythematosus, Systemic, Lupus Glomerulonephritis, Systemic Lupus Erythematosus, Mesenchymal Stromal Cells, Lupus nephritis