Cell Therapy for Immunomodulation in Kidney Transplantation

Launched by THOMAS WEKERLE · Mar 6, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for people receiving a kidney transplant from a living donor. The study focuses on using special immune cells from the transplant recipient, along with bone marrow from the donor and a medication called tocilizumab, to help improve the way the body accepts the new kidney. The goal is to better manage the immune response, which is crucial for the success of the transplant.

To participate in this trial, patients must be at least 18 years old and scheduled to receive a kidney from a living donor that is a good match for their blood type. They cannot have specific antibodies that might complicate the transplant and must not have had a kidney transplant before. Participants will receive detailed information and support throughout the study, which is currently active but not recruiting new patients. It's important for potential participants to understand the eligibility requirements and discuss any questions with their healthcare team.

Gender

ALL

Eligibility 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.