Cell Therapy for Immunomodulation in Kidney Transplantation

  • STATUS
    Recruiting
  • End date
    Apr 26, 2023
  • participants needed
    12
  • sponsor
    Thomas Wekerle
Updated on 26 January 2021
immunosuppressive agents
kidney transplant
immunosuppressants
blood type

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.

Details
Condition Organ Transplantation, Renal transplant, Organ Transplant - Pediatric, Organ Transplant, Kidney Transplantation, kidney transplant, renal transplantation, kidney transplants
Treatment Tocilizumab, Kidney Transplant, Regulatory T cells, Regulatory T cells, Bone marrow, Bone marrow, Immunosuppressive drug therapy
Clinical Study IdentifierNCT03867617
SponsorThomas Wekerle
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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