NCT03917797

Mesenchymal Stromal Cells (MSC´s) in Renal Lupus

Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Universidad de los Andes, Chile · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Phase IIa trial of escalating doses of intravenous (i.v.) MSCs in active SLE, followed by a Phase IIb, triple blind, controlled assessment of the selected MSC dosing versus Placebo, in SLE patients receiving Standard of Care Therapy for Severe Renal Disease,

Conditions

• Lupus Erythematosus, Systemic
• Lupus Glomerulonephritis

Interventions

Type	Name	Description
BIOLOGICAL	MSC treatment	Umbilical cord-derived Mesenchymal Stromal Cell
DRUG	Standard of Care	Methylprednisolone; Cyclophosphamide; Prednisone; Mycophenolate
DRUG	Placebo	MSC infusion vehicle

Timeline

• Start date: 2019-04-02
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2019-04-17
• Last updated: 2023-02-08

Locations

2 sites across 1 country: Chile