Allogeneic Umbilical Cord Mesenchymal Stromal Cells for the Treatment of Chronic Antibody-Mediated Rejection in Kidney Transplantation

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

September 15, 2027

Study Completion Date

October 15, 2029

Conditions
Chronic Antibody-mediated Rejection (cABMR)
Interventions
OTHER

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.

OTHER

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.

Trial Locations (1)

94010

Hôpital Henri Mondor, Créteil

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06886646 - Allogeneic Umbilical Cord Mesenchymal Stromal Cells for the Treatment of Chronic Antibody-Mediated Rejection in Kidney Transplantation | Biotech Hunter | Biotech Hunter