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
Overview
- Phase
- Phase 2
- Intervention
- Mesenchymal stem cells (MSC)
- Conditions
- Lupus Nephritis
- Sponsor
- Red de Terapia Celular
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Proportion of patients who have achieved complete response
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Mesenchymal stem cells (MSC)
Participants will receive a single Intravenous infusion of Mesenchymal Stem Cells (MSV) 2 million cells per kg wt suspended in 100 ml of physiological saline solution. All participants will receive the infusion at the Baseline (Day 0) visit. All participants will continue on their standard-of-care therapy during the trial. GMP-compliant MSV will be prepared by IBGM-University of Valladolid-Citospin.
Intervention: Mesenchymal stem cells (MSC)
Placebo
Participants will receive a placebo infusion (100 ml of physiological saline solution) that does not contain any mesenchymal stem cells.
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of patients who have achieved complete response
Time Frame: 0-24 weeks
Complete renal response criteria: glomerular filtration rate ≥ 60ml/min/1.73m², or decrease to initial values or ± 15% of the baseline value in those with glomerular filtration rate \< 60ml/min/1.73m²; proteinuria ≤ 0.5 g/24h; inactive sediment: ≤ 5 red blood cells, ≤ 5 leukocytes, absence of red blood cell casts; and serum albumin \> 3 g/dl.
Proportion of patients who have achieved partial response
Time Frame: 0-24 weeks
Partial renal response criteria: if baseline proteinuria ≥ 3.5 g/24h, decrease in proteinuria \< 3.5 g/24h; if baseline proteinuria \< 3.5 g/24h, proteinuria reduced by \> 50% compared to baseline; in both situations stabilization (±25%) or improvement in glomerular filtration compared to baseline values.
Secondary Outcomes
- Proportion of patients at week 24 whose prednisone-equivalent corticosteroid dose has been reduced(0-24 weeks)
- Proportion of patients at each visit whose prednisone-equivalent corticosteroid dose has been reduced(Throughout the study until its completion, an average of 1.5 years)
- Proportion of patients who have reduced the dose of immunosuppressants(0-24 weeks)
- Change from baseline in SF-36 score(Throughout the study until its completion, an average of 1.5 years)
- Proportion of patients at week 24 with a specific reduction relative to the selection visit in the daily dose of prednisone-equivalent corticosteroids.(0-24 weeks)
- Cumulative dose of corticosteroids(0-24 weeks)
- Change from baseline in LupusQoL score(Throughout the study until its completion, an average of 1.5 years)
- Change in proteinuria levels(Throughout the study until its completion, an average of 1.5 years)
- Change in disease activity (SLEDAI-2K index)(Throughout the study until its completion, an average of 1.5 years)