Overview
Phase II Clinical Trial to Assess the dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (MSCs) in Severe Renal Systemic Lupus Erythematosus (SLE).
Description
Phase IIa trial of escalating doses of intravenous (i.v.) MSCs in active SLE, followed by a Phase IIb, triple blind, controlled assessment of the selected MSC dosing versus Placebo, in SLE patients receiving Standard of Care Therapy for Severe Renal Disease,
Eligibility
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.