Mesenchymal Stromal Cells (MSC´s) in Renal Lupus (MSC-ROLE)
Lupus Erythematosus, Systemic, Lupus Glomerulonephritis
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Systemic Lupus Erythematosus, Mesenchymal Stromal Cells, Lupus nephritis
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.
Sites / Locations
- Clínica Universidad de los AndesRecruiting
- Hospital Barros Luco TrudeauRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MSC treatment
Placebo
Intervention: a previously selected dose of MSCs (Phase IIa) will be administered by i.v. infusion at baseline and 6 months of follow-up (total 12 months), to patients with Severe Renal SLE subject also to Standard of Care treatment with Methylprednisolone and Cyclophosphamide followed by Mycophenolate.
Intervention: A Placebo (infusion vehicle) will be administered by i.v. infusion at baseline and 6 months of follow-up (total 12 months), to patients with Severe Renal SLE subject also to Standard of Care treatment with Methylprednisolone and Cyclophosphamide followed by Mycophenolate.