Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
39 participants
INTERVENTIONAL
2019-04-02
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
MSC treatment
Umbilical cord-derived Mesenchymal Stromal Cell
Standard of Care
Methylprednisolone; Cyclophosphamide; Prednisone; Mycophenolate
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.
Standard of Care
Methylprednisolone; Cyclophosphamide; Prednisone; Mycophenolate
Placebo
MSC infusion vehicle
Interventions
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MSC treatment
Umbilical cord-derived Mesenchymal Stromal Cell
Standard of Care
Methylprednisolone; Cyclophosphamide; Prednisone; Mycophenolate
Placebo
MSC infusion vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Universidad de los Andes, Chile
OTHER
Responsible Party
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Fernando E. Figueroa MD
Program Director Translational Research in Cell Therapy
Principal Investigators
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Fernando F E, MD
Role: PRINCIPAL_INVESTIGATOR
Professor School of Medicine
Locations
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Clínica Universidad de los Andes
Santiago, Santiago Metropolitan, Chile
Hospital Barros Luco Trudeau
Santiago, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Phase II Lupus MSC
Identifier Type: -
Identifier Source: org_study_id
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