Cell Therapy for Immunomodulation in Kidney Transplantation

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Wekerle
• Collaborator: University Hospital Regensburg
• Treatments: Immunosuppressive Agents

Criteria

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.