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,
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Mesenchymal Stromal Cells (MSC´s) in Renal Lupus
