drugset / Trial / NCT03673748
Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
Phase 2
Recruiting
20 enrolled
Red de Terapia Celular
Citospin · collabHospital Clínico Universitario de Valladolid · collabHospital del Rio Hortega · collabUniversity of Valladolid · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2022-12-27
- Primary completion
- 2026-12
- Completion
- 2027-12
Publications
- Background Vega A, Martin-Ferrero MA, Del Canto F, Alberca M, Garcia V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sanchez A, Garcia-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678.
- Background Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Sanchez A, Garcia-Sancho J. Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1945-1951. doi: 10.1097/TP.0000000000001484.
- Background Barbado J, Tabera S, Sanchez A, Garcia-Sancho J. Therapeutic potential of allogeneic mesenchymal stromal cells transplantation for lupus nephritis. Lupus. 2018 Nov;27(13):2161-2165. doi: 10.1177/0961203318804922. Epub 2018 Oct 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rexlemestrocel-L | Cell therapy | 2e+06 cells/kg | Intravenous |