CTIS2024-513459-34-00
Recruiting
Phase 1
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 (Trex) - Trex001
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Kidney transplantation
- Sponsor
- Medical University Of Vienna
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For recipients (study and control group): Patient has provided written informed consent., For donors (study group only): Participant is 18 years or older., For donors (study group only): Participant is suitable to donate bone marrow according to the guidelines of the Department of Blood Group Serology and Transfusion Medicine., For donors (study group only): WOCBP must not be pregnant at inclusion (i.e. negative pregnancy test)., For donors (control group only): Participant has provided written informed consent to donate blood for immune monitoring analyses., For donors (control group only): Participant is 18 years or older., For recipients (study and control group): Patient is 18 years or older., For recipients (study and control group): Patient is a planned recipient of a living donor kidney transplant., For recipients (study and control group): Patient is a planned recipient of an ABO\-compatible kidney graft., For recipients (study and control group): Patient is a planned recipient of a kidney graft from a donor that is not HLA\-identical., For recipients (study and control group): Patient is negative for DSA., For recipients (study and control group): WOCBP must have a negative pregnancy test at inclusion., For recipients (study and control group): 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., For donors (study group only): Participant has provided written informed consent.
Exclusion Criteria
- •For recipients (study and control group): Patient is EBV\-negative on serology., For recipients (study and control group): Patient is HIV\-positive or suffering from chronic viral hepatitis., For recipients (study and control group): Patient is CMV\-negative and receiving a kidney from a CMV\-positive donor., For recipients (study and control group): Positive T\-cell lymphocytotoxic cross match., For recipients (study and control group): Patient with prior kidney transplant or non\-renal solid organ transplant., For recipients (study and control group): Patient has a known contraindication to any of the protocol\-specified treatments, For recipients (study and control group): 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., For recipients (study and control group): Female patients who are breast\-feeding., For recipients (study and control group): Female patients with a positive pregnancy test.
Outcomes
Primary Outcomes
Not specified
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