The TWO Study aims to assess the feasibility of reducing immunosuppression in renal transplant recipients with the use of regulatory T cells (Treg). The trial will be led by the University of Oxford’s Dr Fadi Issa (PI), Dr Paul Harden (Co-PI & Clinical Lead), Professor Peter Friend (Chief Investigator) and Dr Joanna Hester (Immune Biology Lead), together with Professor Giovanna Lombardi of King’s College London, senior researchers from TRIG, the Oxford Transplant Centre, the University’s Surgical Trials Intervention Unit, Oxford University Innovation, and the BRC GMP facility at Guy’s and St Thomas’ NHS Foundation Trust.
The trial aims to recruit 68 patients over a three-year period, with those receiving the cellular therapy donating a unit of blood for isolation of Tregs. Isolated Treg will then be expanded in a purpose-built GMP facility at Guy's Hospital in London. The function of kidney transplants will be assessed and the amount of drug-based immunosuppression reduced accordingly. Patients will be closely monitored and potential early markers of improved immune function will be determined using advanced assessment techniques.
For more information about the project please contact Monica Dolton, the Project Manager.