Last updated 22 months ago
Mesenchymal Stromal Cells (MSC´s) in Renal Lupus
39 patients around the world
Available in Chile
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,
Universidad de los Andes, Chile
2Research sites
39Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Fulfilling 1997 updated American College of Rheumatology (ACR) Criteria or 2012 SLICC Classification Criteria for SLESeropositive for antinuclear (≥1:80) and/or anti-DNA antibodiesFulfilling 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
- Estimated GFR < 40ml/min/m2Addition 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 CyclophosphamideAddition during prior 12 months of randomization of Biological anti-B cell therapyCoexisting uncontrolled morbidity; Pregnancy or planned Pregnancy within next 12 months; uncontrolled infection or neoplastic disease. Pending unresolved surgical indication.
Sites
Clínica Universidad de los Andes
Recruiting
Hospital Barros Luco Trudeau
Recruiting
StudyMSC-ROLE
SponsorUniversidad de los Andes, Chile
Study typeInterventional
Conditions
Systemic lupus erythematosus
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03917797
