CELLEUROPE · Improving HSCT By Validation Of Biomarkers & Development Of Novel Cellular Therapies

Novel transplant regimens are currently being developed to improve beneficial GvL effects and reduce GvHD and infections via several new forms of cellular therapies. This newly emerging supra-disciplinary field of cellular therapy and regenerative medicine is also being used to improve outcomes in autoimmune disease (such as Rheumatoid Arthritis) and cancers. The goal of this research programme is to gain insight into the mechanisms of action of GvL and GvHD in order to improve current therapies and develop and test novel ones via clinical trials and/or animal model experiments. The research is therefore necessarily multidisciplinary including clinical medicine, immunology, genomics, proteomics, molecular biology and pathology. In order to implement cellular therapies across Europe the current EU Directive 2001/83/EC applies. These regulations stipulate that the cellular therapies which are advanced therapeutic medical products (ATMP) must be produced under current Good Manufacturing Practice (cGMP). Not only is there a lack of understanding of GvL vs. GvHD effects but there is also a lack of training in cGMP for both clinical and non-clinical scientists. We aim to re-address these basic current needs, as well as those of industry, which include lack of access to clinical tissue for validation of bio-markers prior to commercialisation.