Cell Therapy for Immunomodulation in Kidney Transplantation
Phase 1
Active, not recruiting
- Conditions
- Kidney Transplantation
- Interventions
- Other: Regulatory T cellsOther: Immunosuppressive drug therapyOther: Bone marrowProcedure: Kidney transplant
- Registration Number
- NCT03867617
- Lead Sponsor
- Thomas Wekerle
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Bone marrow Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients Study group Kidney transplant Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients Control group Immunosuppressive drug therapy Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients Control group Kidney transplant Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients Study group Tocilizumab Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients Study group Immunosuppressive drug therapy Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients Study group Regulatory T cells Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients
- Primary Outcome Measures
Name Time Method Chimerism 1 month Total leukocyte donor chimerism in blood.
Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death 12 months Incidence of composite safety endpoint by 12 months post-transplant.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna/Vienna General Hospital
🇦🇹Vienna, Austria