We have developed a novel strategy for regenerative medicine to recover tissue functions using temperature-responsive cell culture surfaces. To overcome the disadvantages of conventional methods such as the usage of single-cell suspension injections and biodegradable polymer scaffolds, we use transplantable cell sheets fabricated with temperature-responsive culture surfaces for cell delivery. Here, we summarize our progress in promoting regenerative medicine using cell-sheet engineering with respect to research and regulatory systems and describe recent challenges in the standardization of cell-sheet engineering.