Clinical trial assessing the safety and efficacy of human bone marrow-derived allogeneic mesenchymal stem cell therapy for chronic active antibody-mediated rejection in kidney transplant recipients
Abstract
BACKGROUND AIMS
This study evaluated the safety and efficacy of allogenic human bone marrow-derived mesenchymal stem cell (hBM-MSC) therapy in kidney transplant recipients (KTR) with chronic active antibody-mediated rejection (cABMR).
METHODS
Seven cABMR patients received four infusions of hBM-MSC (1 × 10⁶ cells/kg), one every other week. The primary outcome was clinical safety, focusing on short-term adverse events. Secondary outcomes included changes in allograft function, mean fluorescence intensity (MFI) of donor-specific anti-human leukocyte antigen antibodies (HLA-DSA), allogenic immune response as determined by ELISPOT, lymphocyte subset analysis, infection-free survival, and graft survival compared to 18 historical controls via propensity score matching.
RESULTS
Seven patients received hBM-MSC therapy at a median of 5.4 years (range, 1.6-15.3) after KT and 8.5 months (range, 1.2-20.6) after the diagnosis of cABMR. Six patients completed treatment, and one patient received two doses. No immediate side effects were observed. One patient developed Pneumocystis jirovecii pneumonia (PJP) 3 weeks after treatment and died 6 weeks post-treatment. Among those who completed therapy, the eGFR slope shifted from -Δ16.6% to -Δ2.4% over the 6 month periods before and after treatment, suggesting a stabilization of eGFR decline, proteinuria decreased, and MFI of HLA-DSA declined. T-cell subset analysis showed increased CD8+CD45RA+CCR7- T cells and CD4+CD25+CD127low T cells with…
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