Clinical trial NCT03867617: Cell Therapy for Immunomodulation in Kidney Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Kidney Transplantation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University Hospital Regensburg
First posted: 2019-03-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death
timeFrame: 12 months
measure: Chimerism
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna/Vienna General Hospital
Study officials:
affiliation: Medical University of Vienna
name: Thomas Wekerle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.