Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
- Conditions
- Lupus NephritisLupus Erythematosus
- Interventions
- Drug: Mesenchymal stem cells (MSC)Drug: Placebo
- Registration Number
- NCT03673748
- Lead Sponsor
- Red de Terapia Celular
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mesenchymal stem cells (MSC) 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. Placebo Placebo Participants will receive a placebo infusion (100 ml of physiological saline solution) that does not contain any mesenchymal stem cells.
- Primary Outcome Measures
Name Time Method Proportion of patients who have achieved complete response 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 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 Outcome Measures
Name Time Method Proportion of patients at week 24 whose prednisone-equivalent corticosteroid dose has been reduced 0-24 weeks The corticosteroid reduction is defined as reduction by ≥ 25% in comparison with the selection visit and to a dose ≤ 7.5 mg/day and who have no exacerbation BILAG A or 2B. A BILAG A or 2B exacerbation is defined as at least one new BILAG A organic domain score or at least 2 new BILAG B organic domain scores compared to the selection visit.
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 The corticosteroid reduction is defined as reduction by ≥ 25% in comparison with the selection visit and at a dose ≤ 7.5 mg/day, and who do not have any BILAG A or 2B exacerbations of disease activity.
Proportion of patients who have reduced the dose of immunosuppressants 0-24 weeks Proportion of patients who, up to week 24, have reduced the dose of immunosuppressants without presenting any BILAG A or 2B exacerbation.
Change from baseline in SF-36 score Throughout the study until its completion, an average of 1.5 years Quality of life questionnaire (SF-36)
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 Different levels of corticosteroid dose reduction: 0-\<25%, 25%-50%, \>50%.
Cumulative dose of corticosteroids 0-24 weeks Cumulative dose of corticosteroids equivalent to prednisone up to week 24
Change from baseline in LupusQoL score Throughout the study until its completion, an average of 1.5 years Quality of life questionnaire specific for LES (LupusQoL)
Change in proteinuria levels Throughout the study until its completion, an average of 1.5 years Change from baseline in the levels of proteinuria, a sign of disease activity
Change in disease activity (SLEDAI-2K index) Throughout the study until its completion, an average of 1.5 years Change in disease activity measured by change from baseline of Systemic Lupus Erythematosus Disease Activity (SLEDAI-2K) index, which computes the score of different parameters.
Trial Locations
- Locations (1)
University Hospital Río Hortega
🇪🇸Valladolid, Spain