NCT03673748: MSV_LE

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

Recruiting now Phase 2 Last updated 21 July 2025

What this trial tests

Phase 2 trial testing Mesenchymal stem cells (MSC) in Lupus Nephritis in 20 participants. Currently enrolling.

Timeline

27 December 2022

Primary endpoint
1 December 2026

1 December 2027

Quick facts

Lead sponsor	Red de Terapia Celular
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	27 December 2022
Primary completion	1 December 2026
Estimated completion	1 December 2027
Sites	1 location across Spain

Drugs / interventions tested

• Mesenchymal stem cells (MSC) — full drug profile →
• Placebo

Conditions studied

• Lupus Nephritis — all drugs for Lupus Nephritis →
• Lupus Erythematosus — all drugs for Lupus Erythematosus →

Sponsor

Red de Terapia Celular — full company profile →

Who can join

18 and older, any sex, with Lupus Nephritis or Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
   Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
2. Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
   Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
3. Melatonin preconditioning is an effective strategy for mesenchymal stem cell-based therapy for kidney disease.
   Zhao L, Hu C, Zhang P, Jiang H, et al · · 2020 · cited 37× · PMID 31747719 · DOI 10.1111/jcmm.14769
4. Mesenchymal Stem Cell Therapy in Kidney Diseases: Potential and Challenges.
   Chen F, Chen N, Xia C, Wang H, et al · · 2023 · cited 30× · PMID 37013255 · DOI 10.1177/09636897231164251
5. Enhancing Mesenchymal Stromal Cell Immunomodulation for Treating Conditions Influenced by the Immune System.
   Guerrouahen BS, Sidahmed H, Al Sulaiti A, Al Khulaifi M, et al · · 2019 · cited 27× · PMID 31467564 · DOI 10.1155/2019/7219297
6. When Origin Matters: Properties of Mesenchymal Stromal Cells From Different Sources for Clinical Translation in Kidney Disease.
   Calcat-I-Cervera S, Sanz-Nogués C, O'Brien T. · · 2021 · cited 24× · PMID 34616756 · DOI 10.3389/fmed.2021.728496
7. New developments in systemic lupus erythematosus.
   Tsang-A-Sjoe MWP, Bultink IEM. · · 2021 · cited 23× · PMID 34951924 · DOI 10.1093/rheumatology/keab498
8. Current cell therapies for systemic lupus erythematosus.
   Dao LTM, Vu TT, Nguyen QT, Hoang VT, et al · · 2024 · cited 16× · PMID 38920310 · DOI 10.1093/stcltm/szae044