Cell Therapy for Immunomodulation in Kidney Transplantation

This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.

Inclusion Criteria: * Patient has provided written informed consent. * Patient is 18 years or older. * Patient is a planned recipient of a living donor kidney transplant. * Patient is a planned recipient of an ABO blood group-compatible kidney graft. * Patient is a planned recipient of a kidney graft from a donor that is not HLA (human leukocyte antigen)-identical. * Patient is negative for DSA (donor-specific antibodies). * WOCBP (women of child-bearing potential) must have a negative pregnancy test at inclusion. * WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: * Patient is EBV (epstein barr virus)-negative on serology. * Patient is HIV-positive or suffering from chronic viral hepatitis. * Patient is CMV (cytomegalo virus)-negative and receiving a kidney from a CMV-positive donor. * Positive T-cell lymphocytotoxic cross match. * Patient with prior kidney transplant or non-renal solid organ transplant. * Patient has a known contraindication to any of the protocol-specified treatments. * Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin. * Female patients who are breast-feeding. * Female patients with a positive pregnancy test.