Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus
Who is this study for? Patients with Lupus Glomerulonephritis
What treatments are being studied? Standard of Care Treatment
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Chile
Clínica Universidad de los Andes
RECRUITING
Santiago
Hospital Barros Luco Trudeau
RECRUITING
Santiago
Contact Information
Primary
Fernando F E, MD
ffigueroa@uandes.cl
+56226181455
Backup
Francisco Espinoza, MD
fespinoza@c4c.cl
+56226181008
Time Frame
Start Date: 2019-04-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 39
Treatments
Experimental: MSC treatment
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.
Placebo_comparator: Placebo
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.
Related Therapeutic Areas
Sponsors
Leads: Universidad de los Andes, Chile