Cell Therapy for Immunomodulation in Kidney Transplantation

Sponsor
Thomas Wekerle
Study ID
NCT03867617
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Kidney Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Regulatory T cells — OTHER
    Single infusion of expanded regulatory T cells.
  • 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.

Study Details

This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.

Key Dates

Start date
Aug 1, 2019
Status verified
Nov 2024
Primary completion
Jun 30, 2024
Completion
Jun 30, 2028

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study group
    Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients
  • Active Comparator: Control group
    Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients

Primary Outcome Measure

Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death [ Time Frame: 12 months ]

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