Organ transplantation rates have improved considerably over the years but the use of immunosuppressive medication is linked with significant side effects. For example, in the case of the life-threatening end-stage renal disease, long-term treatment with immunosuppressive drugs can lead to chronic kidney graft failure, infections and cancer. The EU-funded THE ONE STUDY (A unified approach to evaluating cellular immunotherapy in solid organ transplantation) project will perform clinical trials to decipher if use of regulatory immune cells in patients with organ transplantations could reduce the need for immunosuppressant drugs. In this context, participating teams have worked to license several regulatory cell products under good manufacturing practice conditions and will test them in a coordinated clinical study. So far, the reference group trial has enrolled 70 patients with a living-donor kidney transplant and treated them with a standard immunosuppressive regimen. The cell therapy trial is a collaborative effort across Europe and involves the administration of regulatory T cells, dendritic cells or monocytes at escalating doses in transplanted patients. The ongoing activities will also address the common and unique mechanisms of the suppressive action of the different regulatory cell populations. To track the path and duration of infused cells, the consortium has developed an innovative technology using laser ablation inductively coupled plasma mass spectrometry in combination with gold and gadolinium labelling. The approach has so far been tested only at the pre-clinical level in animal models. THE ONE STUDY project outcomes should provide cell therapy products that will significantly improve the outcome for transplant recipients and reduce associated healthcare costs. The knowledge garnered on the mechanism of action of each cell type will help adapt the treatment to maximise clinical benefit.
Cell therapy, organ transplantation, clinical trial, regulatory T cells