Regulations of Regenerative Medicine Including Clinical Application of iPS Cells in Japan

Clinical studies of regenerative medicine using induced pluripotent stem (iPS) cells have recently been performed, especially in Japan. To promote regenerative medicine research using iPS cells, the related laws have been enacted in Japan, leading to the use of other bioresources. Here, we overview the legislation of regenerative medicine. In parallel with this legislation, Kyoto University Hospital and the Center for iPS Cell Research and Application (CiRA) at Kyoto University, Japan, have rapidly established a bioresource stocking system for the purpose of clinical study and therapy using iPS cells. Kyoto University Hospital and CiRA are now preparing for the use of stocked iPS cells and other bioresources based on joint research contracts between Kyoto University and external institutions.