drugset / Trial / NCT03580291

Human Umbilical Cord Mesenchymal Stem Cells Treatment for Lupus Nephritis (LN)

NCT03580291 ↗

Phase 2 Unknown 230 enrolled Lingyun Sun
RandomizedParallel-groupDouble-blindTreatment

Summary

Lupus nephritis (LN) is one of the most serious complications and the main cause of death in patients with systemic lupus erythematosus (SLE).The investigators have investigated the usefulness, and confirmed the efficacy and safety of mesenchymal stem cells (MSC) treatment of LN in animal models, in vitro experiments and phase I clinical trial. In this study, a randomized, placebo-controlled, parallel group, non-inferiority, prospective, multicenter clinical trial is performed to investigate the efficacy and safety of MSC transplantation in the treatment of LN compared to mycophenolate mofetil (MMF).

Timeline

Start
2018-08-01
Primary completion
2021-06-01
Completion
2021-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycophenolate Mofetil Small molecule 2 g Oral

Indications