Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRed de Terapia Celular
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mesenchymal stem cells (MSC)
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Red de Terapia Celular
Lead sponsor
Hospital del Rio Hortega
Collaborator
Hospital Clínico Universitario de Valladolid
Collaborator
University of Valladolid
Collaborator
Citospin
Collaborator
Source ClinicalTrials.gov