2018 Volume 28 Issue 1 Pages 103-113
Research in the field of regenerative medicine using cells symbolized by iPS cells has greatly advanced in the past decade, and its results are highly expected for clinical application. In Japan, regulation revision to apply regenerative medicine to clinical use has been carried out, and it gained worldwide attention. Based on the research results of Osaka University, Terumo Corporation acquired the approval of regenerative medicine product ‘Heart Sheet’ by autologous cells that can adapt to severe heart failure as first product in the world. This development could be achieved by revising the regulation in Japan. Also, this is a result of collaboration between industry, government and academia. However, there is few products in Japan compared to the number of regenerative medicine products in Europe and the United State.
In this paper, I summarize the circumstances of our development, and the change of regulation and related information. And, from the standpoint of the industrial side, I discussed changes in the development environment and current issue.
