NCT03673748

Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

Phase II, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate Safety and Efficacy of Mesenchymal Stem Cells (MSV-allo) in the Treatment of Lupus Nephritis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Red de Terapia Celular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis. The objective of this study is to evaluate the efficacy of mesenchymal stem cells (MSCs) in achieving a full or partial response in the treatment of Lupus Nephritis (LN) during its induction period.

Detailed description

A Phase 2b, double-blind (neither the participant nor the investigator will know if active drug or placebo is assigned), placebo-controlled, randomized (assigned by chance), in which subjects with Lupus Nephritis (LN), who do not respond -or respond partially- to induction treatment, shall receive either MSCs (2 million cells/Kg) or placebo by intravenous injection. The administration of cells will be done only once.

Conditions

• Lupus Nephritis
• Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Mesenchymal stem cells (MSC)	Endovenous injection of MSV in saline solution
DRUG	Placebo	Endovenous injection of saline solution without cells

Timeline

• Start date: 2022-12-27
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2018-09-17
• Last updated: 2025-07-24

Locations

1 site across 1 country: Spain