Cellular Therapeutics – Living Drugs: A Rising Star at the Horizon of Immunotherapy in Hematology and Oncology

Until recently, only the transplantation of autologous or allogeneic hematopoietic stem and progenitor cells after conditioning therapies had been well established for more than 4 decades reaching more than 1 million successful transplantations worldwide. During the last years two cellular therapeutics, allogeneic, third-party mesenchymal stromal cells (MSC) and autologous chimeric antigen receptor T cells (CAR-T cells), finally succeeded to prove clinical effectiveness and safety and have now been introduced into the clinic. In August 2016, the German health authorities (Paul Ehrlich Institute) approved an allogeneic MSC product deduced from pooled bone marrow mononuclear cells. Subsequently, data of a clinical trial published in 2018 [1] showed the clinical effectiveness and safety of this living drug. CAR-T-cell treatment in cancer is a challenge with worldwide more than 200 studies at the end of 2016 and exceeding 450 studies to date. In August 2017, the FDA approved the first CAR-T-cell therapy. In addition both drugs can now be purchased commercially in different formulations probably marking a milestone for the further evaluation and development of such therapies. Therefore several aspects with respect to clinical application as well as potential problems and future developments in this area of living drugs are addressed in this issue of Transfusion Medicine and Hemotherapy