Clinical trial NCT03917797: Mesenchymal Stromal Cells (MSC´s) in Renal Lupus
Official title: Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Lupus Glomerulonephritis
Keywords: Systemic Lupus Erythematosus
Mesenchymal Stromal Cells
Lupus nephritis
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Superiority trial comparing MSCs versus Placebo in SLE patients with severe renal disease receiving Standard of Care treatment.
Primary purpose: TREATMENT

Brief 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).

Detailed 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 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.

Primary outcomes:
measure: Achievement of Global Renal Response (GR) at Study Endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Achievement of Complete Renal Response (CR) at Study Endpoint
timeFrame: 12 months
measure: Achievement of Partial Renal Response (PR) at Study Endpoint
timeFrame: 12 months
measure: Treatment Failure
timeFrame: 24 weeks and 12 months
measure: Response of SLE Responder Index (SRI).
timeFrame: 12 months
measure: Selena Sledai
timeFrame: 12 months
measure: BILAG score
timeFrame: 12 months
measure: Disease Flares
timeFrame: 12 months
measure: Biomarker Response
timeFrame: 24 weeks and 12 months
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Clínica Universidad de los Andes
state: Región Metropolitana
city: Santiago de Chile
country: Chile
facility: Hospital Barros Luco Trudeau
state: Región Metropolitana
Study officials:
affiliation: Professor School of Medicine
name: Fernando F E, MD
role: PRINCIPAL_INVESTIGATOR
References: