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Mesenchymal Stromal Cells (MSC´s) in Renal Lupus

NCT03917797 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-02-08

No results posted yet for this study

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

Interventions

BIOLOGICAL

MSC treatment

Umbilical cord-derived Mesenchymal Stromal Cell

DRUG

Standard of Care

Methylprednisolone; Cyclophosphamide; Prednisone; Mycophenolate

DRUG

Placebo

MSC infusion vehicle

Sponsors & Collaborators

  • Universidad de los Andes, Chile

    lead OTHER

Principal Investigators

  • Fernando F E, MD · Professor School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Chile

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03917797 on ClinicalTrials.gov