22
Participants
Start Date
September 15, 2025
Primary Completion Date
September 15, 2027
Study Completion Date
October 15, 2029
Allogeneic Mesenchymal Stromal Cell Therapy
Patients in this arm will receive 4 injections of allogeneic mesenchymal stromal cells (CSM) derived from human umbilical cord. The doses will be 1.106 cells/kg administered intravenously at days 0, 7, 14, and 21. The injections are given after thawing, washing, resuspension, and adjusting the dose. The CSM treatment aims to control chronic active antibody-mediated rejection (cABMR), improve renal function, reduce proteinuria, and increase graft survival without changing the immunosuppressive regimen.
Placebo (NaCl 0.9%) Treatment
Patients in this arm will receive placebo treatments, which will consist of 150 mL of saline (NaCl 0.9%) administered intravenously at the same intervals as the CSM group (days 0, 7, 14, and 21). The placebo will be administered under the same conditions as the treatment, and the participants and investigators will remain blinded to the group allocation. Like the CSM group, no changes will be made to the patients' immunosuppressive regimen.
Hôpital Henri Mondor, Créteil
Assistance Publique - Hôpitaux de Paris
OTHER