Cell Therapy for Immunomodulation in Kidney Transplantation
NCT ID: NCT03867617
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2019-08-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study group
Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients
Regulatory T cells
Single infusion of expanded regulatory T cells.
Tocilizumab
Treatment during first month post-transplant.
Bone marrow
Infusion of donor bone marrow cells.
Kidney transplant
Living donor kidney transplantation.
Immunosuppressive drug therapy
Immunosuppressive drug therapy.
Control group
Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients
Kidney transplant
Living donor kidney transplantation.
Immunosuppressive drug therapy
Immunosuppressive drug therapy.
Interventions
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Regulatory T cells
Single infusion of expanded regulatory T cells.
Tocilizumab
Treatment during first month post-transplant.
Bone marrow
Infusion of donor bone marrow cells.
Kidney transplant
Living donor kidney transplantation.
Immunosuppressive drug therapy
Immunosuppressive drug therapy.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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University Hospital Regensburg
OTHER
Thomas Wekerle
OTHER
Responsible Party
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Thomas Wekerle
Professor of Transplantation Immunology
Principal Investigators
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Thomas Wekerle, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna/Vienna General Hospital
Vienna, , Austria
Countries
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References
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Oberbauer R, Edinger M, Berlakovich G, Kalhs P, Worel N, Heinze G, Wolzt M, Lion T, Wekerle T. 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 (Trex001). Front Med (Lausanne). 2021 Jan 27;7:634260. doi: 10.3389/fmed.2020.634260. eCollection 2020.
Other Identifiers
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Trex001
Identifier Type: -
Identifier Source: org_study_id