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| Name | Class |
|---|---|
| University Hospital Regensburg | OTHER |
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This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients |
|
| Control group | Active Comparator | Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regulatory T cells | Other | Single infusion of expanded regulatory T cells. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death | Incidence of composite safety endpoint by 12 months post-transplant. | 12 months |
| Chimerism | Total leukocyte donor chimerism in blood. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Wekerle, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna/Vienna General Hospital | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33585521 | Derived | 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. |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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| Tocilizumab |
| Drug |
Treatment during first month post-transplant. |
|
| Bone marrow | Other | Infusion of donor bone marrow cells. |
|
| Kidney transplant | Procedure | Living donor kidney transplantation. |
|
| Immunosuppressive drug therapy | Other | Immunosuppressive drug therapy. |
|
| D013514 |
| Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |