Integrated training in development and clinical practice of cell-based therapies

? DESCRIPTION (provided by applicant): The stem cell therapy market is valued at $2.7 billion, currently consisting largely of the hematopoietic stem cell (HSC) transplant market. HSC therapies are growing at roughly 10.6 % compound growth rate, and the advancement in stem cell therapies is broadening beyond the treatment of hematological malignancies into the treatment of cardiovascular, neurological, and other disorders. Blood products provide raw material for the manufacturing of several novel cell therapies, including stem cells and immune cell therapies. With promising early results in trials with natural killer (NK) cells, chimeric antgen receptor T-cells (CAR-T cells), antigen-specific T cells, mesenchymal stem/stromal cells, and others, the field will only continue to expand. With a decline in scientists in blood-based research, it is critical to the success of the field of cell therapy to focus efforts on training crrent researchers, as well as new investigators, perhaps contemplating a direction. New investigators as well as scientists who may be trained in the fundamentals of blood-based research may lack experience scaling up the techniques from the bench to the bedside. Specifically, they may not have experience in the advanced techniques used to process blood and stem-cell based therapies, and the sophisticated assays used for product characterization and post-treatment patient assessment. Furthermore, most investigators do not have experience with the regulatory requirements of cell-based therapies, a definite challenge in moving potential therapies from the bench to the bedside. An integrated education program in development and clinical practice of cell-based therapies would be instrumental in countering the decline of blood-based investigators and fostering advances in the treatment of hematological and other disease. The University of Minnesota (UM) is ideally positioned to provide such a program, with a proven track record of development of cellular therapies. The cGMP facility of the UM, Molecular & Cellular Therapeutics (MCT), has been highly successful as a member of the Production Assistance for Cellular Therapies (PACT) group, an NHLBI-sponsored contract. MCT has been an integral part of several well- received PACT webinars and facility workshops and education programs with professional organizations (e.g., AABB and ISCT) [3] and has educated numerous medical students, residents, fellows, and visiting scholars from around the world. The Biopreservation Core Resource (BioCoR) at the UM is the nations only resource in preservation and has training courses in preservation of cellular therapies and research into technology and methods of preservation for cellular therapies. These resources and a host makes the UM well suited to offer this short term educational experiences to enrich the hematology workforce. (End of Abstract)