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Research Summary

The TWO Study is a single centre phase IIb randomised controlled trial of regulatory T cell therapy in renal transplantation.  In this study we will obtain naturally occurring regulatory T cells (Treg) from patients prior to transplantation and expand such cells to far greater numbers in the laboratory.  The expanded cells will then be re-infused into the transplant recipient 6 months post-transplantation.  We aim to demonstrate that this approach will tip the balance of the immune system away from transplant rejection and allow us to reduce the need for pharmaceutical immunosuppression which carries with it intrinsic, life-limiting, side effects.

Background to the trial

Patients undergoing organ transplantation are required to take life-long medication to prevent rejection.  Whilst such medications are essential and highly effective they carry with them a substantial burden of side-effects including an increased risk of life-threatening events such as severe infection, heart disease, cancer and diabetes.  Numerous experimental models have demonstrated that naturally occurring regulatory T cells (Treg) may be used to prevent the rejection of transplanted organs and there is now great interest in bringing cell therapy into the clinical setting.  We have previously taken part in a phase 1 trial of regulatory T cell infusion in kidney transplantation, The ONE Study.  The ONE Study isolated naturally occurring Treg from patients due to undergo living donor kidney transplantation.  Treg were subsequently expanded to far greater numbers in the laboratory and then re-infused into the same patient after transplantation in a dose escalation manner.  The ONE Study demonstrated that Treg infusion could be performed successfully and safely.  We are now looking to expand our experience through The TWO Study. The TWO Study aims to demonstrate that we might utilise infusions of expanded Treg to reduce the need for anti-rejection medications and therefore reduce exposure to their intrinsic life-limiting side-effects.

Aims and Objectives

To compare the efficacy of autologous regulatory T cell therapy used in conjunction with tacrolimus to standard of care immunosuppression (MMF and tacrolimus) in preventing acute biopsy-proven rejection in renal transplant recipients.

Study Design

Single-centre, open-label, randomised-controlled Phase IIb trial in 68 patients.