Cell Therapy for Immunomodulation in Kidney Transplantation

A Prospective Controlled Trial to Evaluate Safety and Efficacy of in Vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-mismatched Living Donor Kidney Transplant Recipients

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.