drugset
drugset / Trial / NCT02633163

Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)

NCT02633163 ↗

Phase 2 Completed 81 enrolled Medical University of South Carolina
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC infusion plus standard of care respond better than patients receiving placebo infusion plus standard of care.

Timeline

Start
2018-11-18
Primary completion
2025-08-05
Completion
2026-02-03

Drugs

EvaluationDrugModalityDoseRoute
Subject mesenchymal stem cells Cell therapy 1 cells/kg Intravenous
Subject mesenchymal stem cells Cell therapy 5 cells/kg Intravenous

Indications

systemic lupus erythematosus