MedTrace Logo

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

NCT03580291 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2018-07-10

No results posted yet for this study

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).

Conditions

Interventions

OTHER

Mesenchymal stem cells

The group receive pulse infusion of MSCs once of 2 x 10\^6/kg body weight

DRUG

Mycophenolate Mofetil

This group receive oral MMF of 2.0 g / d.

OTHER

Placebo of Mesenchymal stem cells

The group receive placebo of Mesenchymal stem cells.

DRUG

Placebo of Mycophenolate Mofetil

The group receive placebo of oral mycophenolate mofetil.

Sponsors & Collaborators

  • Lingyun Sun

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03580291 on ClinicalTrials.gov