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

NCT03867617 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	Thomas Wekerle
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	12
Start date	2019-08-01
Completion	2028-06

Conditions

• Kidney Transplantation

Interventions

• Regulatory T cells
• Tocilizumab
• Bone marrow
• Kidney transplant
• Immunosuppressive drug therapy

Primary outcomes

• 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.
• Chimerism — 1 month
  Total leukocyte donor chimerism in blood.

Countries

Austria