Background. We performed the first clinical trial in China in which kidney transplantation was combined with donor hematopoietic stem cell (DHSC) infusion for tolerance induction. This study summarizes the 10-year follow-up results. Methods. From 2009 to 2017, 11 cases of living-related kidney transplantation combined with DHSC infusion were performed. Two of them were HLA-matched, and nine were HLA-mismatched. The DHSCs were mobilized using granulocyte colony-stimulating factor and harvested one day before transplantation. The recipients received consecutive total lymphoid irradiation for 3 days before kidney transplantation. The induction drug was anti-thymocyte globulin. DHSCs were infused on the 2 nd , 4 th and 6 th postoperative days. Results. One HLA-matched recipient induced 30-50% chimerism, and the others only induced less than 1% chimerism. Recipients had a low immune response to their donors while sustaining normal reactivity to non-donors in mixed lymphocyte reactions. All recipients were followed up for 717~3,918 days. One recipient lost allograft function, and 10 recipients had stable renal function. None of the 11 recipients had myelosuppression or graft-versus-host disease post transplantation. Our protocol did not increase the risk of infection. Allograft biopsy confirmed that one patient had mild acute rejection, and the other 10 recipients did not develop rejection. Five patients reduced the dose of immunosuppression. Conclusions. This study shows that long-term stable kidney allograft survival may be achieved with low-dose immunosuppression maintenance using our protocol. Trial registration: Chinese Clinical Trial Registry, ChiCTR-TNC-09000399. Registered 22 April 2009 - Retrospectively registered, http://www.chictr.org.cn
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