NCT03673748
Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
Recruiting · Phase 2 · Red de Terapia Celular · registry updated 2026-08-18
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Females or males ≥18 years old who provide written informed consent at the selection visit.
- Diagnosis of systemic lupus erythematosus (SLE) by meeting at least 4 of the 11 criteria included in the American College of Rheumatology (ACR) classification and/or the Systemic Lupus International Collaborating Clinics (SLICC) criteria, at the selection visit.
- Diagnosis of lupus nephritis (LN) using the 2003 classification of the International Society of Nephrology and the Society of Renal Pathology, by biopsy performed no more than 6 months before the selection visit if they enter from the induction period, and no more than one year if they enter with a moderate/severe recurrence.
- No response or partial response to standard treatment, or moderate/severe recurrence of lupus nephritis.
- SLEDAI-2K ≥ 10 during the selection period.
- Women of childbearing potential should use effective methods of contraception to prevent pregnancy.
Exclusion
- A - Related to previous treatments:
- Use of corticosteroids or mycophenolate above the doses allowed for induction, according to the Consensus Document of the Systemic Autoimmune Diseases Group of the Spanish Society of Internal Medicine and the Spanish Society of Nephrology.
- Use of rituximab, belimumab, ocrelizumab or other biologic therapies against B cells in the 6 months prior to selection.
- Use of cyclophosphamide in the 6 months prior to selection.
- Use of any tumor necrosis factor inhibitor treatment in the 6 months prior to selection.
- Use of immunoglobulins in the 6 months prior to selection.