Mesenchymal Stromal Cells (MSC´s) in Renal Lupus

NCT03917797 | Unknown Phase 2 DMC

• 1 other identifier: Phase II Lupus MSC
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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).

Conditions

Lupus Erythematosus, Systemic; Lupus Glomerulonephritis

Keywords

Systemic Lupus Erythematosus; Mesenchymal Stromal Cells; Lupus nephritis

Outcome Measures

Primary Outcomes (1)

• Achievement of Global Renal Response (GR) at Study Endpoint

  Proportion of Patients that achieve Complete (CR) or Partial (PR) Renal Response at Endpoint

  12 months

Secondary Outcomes (8)

• Achievement of Complete Renal Response (CR) at Study Endpoint

  12 months

• Achievement of Partial Renal Response (PR) at Study Endpoint

  12 months

• Treatment Failure

  24 weeks and 12 months

• Response of SLE Responder Index (SRI).

  12 months

• Selena Sledai

  12 months

Study Arms (2)

MSC treatment

EXPERIMENTAL

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.

Biological: MSC treatment; Drug: Standard of Care

Placebo

PLACEBO COMPARATOR

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.

Drug: Standard of Care; Drug: Placebo

Interventions

MSC treatment BIOLOGICAL

Umbilical cord-derived Mesenchymal Stromal Cell

Also known as: Cellistem ® Lupus

MSC treatment

Standard of Care DRUG

Methylprednisolone; Cyclophosphamide; Prednisone; Mycophenolate

Also known as: Standard of Care for Lupus Nephritis

MSC treatment; Placebo

Placebo DRUG

MSC infusion vehicle

Also known as: Placebo (for MSC)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Study Sites (2)

Clínica Universidad de los Andes

Santiago, Santiago Metropolitan, 7591278, Chile

RECRUITING

Hospital Barros Luco Trudeau

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fernando F E, MD

  Professor School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando F E, MD

CONTACT

+56226181455; ffigueroa@uandes.cl

Francisco Espinoza, MD

CONTACT

+56226181008; fespinoza@c4c.cl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking for patients, physicians providing patient care and outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director Translational Research in Cell Therapy

Model Details: Superiority trial comparing MSCs versus Placebo in SLE patients with severe renal disease receiving Standard of Care treatment.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 17, 2019
• Study Start: April 2, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CL (2)