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Reg T cells and The ONE study

Regulatory T Cells - Characterisation and Mechanisms

Background In recent years there has been renewed interest in the study of regulatory T cells that have the capacity to suppress immune responses both in vitro and in vivo. The ability to harness the potential of such cells in clinical transplantation practice may reduce the need for non-specific immunosuppresive therapy that is required to prevent graft rejection, but consequentially increases the risk of infection and malignancy. Previously, we have demonstrated that administration of alloantigen in combination with agents that modulate the function of T cells can lead to the generation of CD4+CD25+ regulatory T cells that are able to prevent rejection. These regulatory T cells depend on IL-10 and CTLA-4 for functional activity.

Current Studies • How and where regulatory T cells are generated and function after transplantation. • If regulatory T cells specific for donor antigens can be expanded in vitro and assesing their potential as cellular therapeutic agents • The mechanism by which regulatory T cells control aggressive immune responses • How immunosuppresive drugs affect the generation and function of regulatory T cells

The ONE Study

The ONE Study is focussed on preventing immunological rejection of transplanted organs without the need for long-term use of pharmacological immunosuppression. 

Transplantation research that concentrates on early strategies that support long-term immunological acceptance of transplants, allowing for at least a reduction in the use of general immunosuppression, would dramatically improve the outcome for transplant recipients and reduce healthcare costs.

A means to achieve this goal has not been realized with pharmacological or biological agents, so we must now look towards new, innovative approaches.  The ONE Study applies the novel concept of cell therapy to human clinical organ transplantation.

This cooperative project aims to develop and trial various immunoregulatory cell products in organ transplantation recipients, allowing a direct comparison of the safety, clinical practicality and therapeutic efficacy of each cell type.

The central focus of the ONE Study project is to: • Produce and manufacture distinct populations of haematopoietic immunoregulatory cells • Comparatively study the tolerogenic characteristics of these regulatory cell types • Test these cell therapy products side by side in a clinical trial involving living donor renal transplant recipients

TRIG is involved in WP 1 – Cell product and licencing- the objectives of which are to perform rigorous preclinical testing on seven haematologic cell products at six partner sites: Regensburg (Mregs, Tregs), Charité-Berlin (Tregs), King's College-London (Tregs), Oxford (Tregs), Milan (Tr1 cells) and Nantes (DCs). The aim is to license these cell products according to GMP standards and EMEA guidelines within three years. Cell products reaching the licensing milestone by three years will then be manufactured for use in the ONE Study clinical trial.