Affiliations: The Center for Advanced Medical Engineering and
Informatics, Osaka University, Osaka, Japan
Note: [] Corresponding author: Akifumi Matsuyama, Department of Somatic
Stem Cell Therapy and Health Policy, Foundation for Biomedical Research and
Innovation, 2-2 Minatojima-minamimachi, Chuo-ku, Kobe, 650-0047, Japan. Tel.:
+81 78 304 8706; Fax: +81 78 304 8707; E-mail: [email protected]
Abstract: A medical system is anticipated, where high-quality medical services
are accessible without anxieties whenever we are ill. Innovative cell-based
regenerative medical/medicinal products, and tissue-engineered medical
products, have been used successfully to overcome certain life-threatening
diseases, and there is still a need to design/produce more of these products.
We translational researchers in regenerative medicine have been trying to
translate our scientific findings from bench to bedside. Advanced therapies
with cell-based regenerative medical/medicinal products constitute one of the
most complex regulatory areas currently approached by clinical research and
development in order to generate novel therapeutic applications for patients
with incurable disease. We often lack the multidisciplinary skills needed to
overcome intricate and complex regulatory tracks and might feel tired from
pursuing clinical realization. Basic researchers and clinicians trying to
translate stem cell biology into clinical practice might feel defeated by the
endless regulatory requirements that apply. In order to help bridge this gap,
in this chapter, we review practical issues that must be confronted in order to
move from "confidence in mechanism" studies in animals into "proof of
concept" studies in human. First, we briefly outline the basic definitions for
cell products in the USA, EU and Japan, followed by a focused discussion of the
pertinent actions of authorities in Japan.
