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Research paper : Development of regenerative medical technology working toward practical application (H. Ohgushi)−159 Synthesiology - English edition Vol.1 No.3 (2009) the Korean Food and Drug Administration (KFDA), and used the product in nearly 3,000 patients.In skin regeneration, which has longer history than cartilage regeneration, various products are available abroad. However, JTEC only recently obtained approval for regenerative medical product in Japan. The commercialization of regenerative medicine in Japan is obviously slow compared to other countries. The slowness of authorization and approval in Japan is evident. In the future, to promote commercialization of regenerative medicine, the government must work to establish the scientific basis for safety and efficacy of regenerative medical products.Currently, the Medical Affairs Law regulates the Japanese medical system in business phase. For example, drugs and medical devices must undergo the process of clinical trial as designated by the Medical Affairs Law before they can be marketed. This law is based on assumption that the product will be sold to the general public. However, regenerative medicine where cells are isolated from a patient, cultured and grown, and then transplanted back to the same patient, is a technique in which the patients’ own cells (autologous cell) are used. It is medical treatment for specific individual, and therefore, the Pharmaceutical Affairs Law that targets the general public may not be applicable for the treatements. Moreover, in regenerative medicine, the physician must harvest the cells from patient, and one-to-one relationship between physician and patient is established before the actual transplantation of cells, and thorough information are given on the risk and benefit of regenerative treatment using autologous cell before patient’s consent is obtained. Regenerative medicine using autologous cell is clearly different from treatment using someone else’s (allogenic) cell, and new approval system must be considered for this medical technology[9]. New system that is not bound by conventional concept must be created to deal with new technological development including regenerative medicine.AcknowledgementsThis paper was written with cooperation of the people of Tissue Regenerative Engineering Research Group, Research Institute for Cell Engineering. Particularly, active cooperation of Motohiro Hirose for international standard was essential. For development of automatic cell observation device, I thank Mr. Masaki Harada of Biomedical Business Division and Mr. Hiroshi Yamamoto of Human Ecology Research Center, in joint development with Sanyo Electric Co., Ltd with support for “Development of Automatic Observation System of Cultivation Status” of the New Machine System Diffusion and Promotion Business. For measurement device for cell thickness, I thank Mr. Hiroshi Fukuda of Medical New Business Project, as this is joint research with Olympus Corporation with contract from New Energy and Industrial Technology Development Organization (NEDO), as part of Health Program “Development of Evaluation Technology for Early Introduction of Regenerative Medicine.”References[1][2][3][4][5][6][7][8][9]H. Ohgushi and AI. Caplan: Stem cell technology and bioceramics: From cell to gene engineering, J. Biomed. Mat. Res., 48(6), 913-27 (1999).H. Yamamoto, M. Harada, A. Michida, M. Houjou, Y. Yokoi, A. Sakaguchi, H. Ohgushi, A. Ohshima and S. Tsutsumi: Development of cell culture system equipped with automated observation function, J. Biomechanical Science and Engineering, 2(3), 127-137 (2007).Y. Katsube, M. Hirose, C. Nakamura and H. Ohgushi: Biochem. Biophys. Res. Commun.,368(2), 256-260 (2008).H. Ohgushi, Y. Dohi, T. Katuda, et al.: In vitro bone formation by rat marrow cell culture, J. Biomed. Mat. Res., 32, 333-40 (1996).Y. Tohma, Y. Tanaka, H. Ohgushi, et al.: Early bone in-growth ability of alumina ceramic implants loaded with tissue-engineered bone, J. Orthop. Res., 24, 595-6037 (2006).H. Ohgushi, N. Kotobuki, H. Funaoka, et al.: Tissue engineered ceramic artificial joint - ex vivo osteogenic differentiation of patient mesenchymal cells on total ankle joints for treatment of osteoarthritis, Biomaterials, 26(22), 4654-61 (2005).T. Morishita, T. Honoki, H. Ohgushi, et al.: Tissue engineering approach to the treatment of bone tumors: three cases of cultured bone grafts derived from patients mesenchymal stem cells, Artif. Organs, 30(2), 115-8 (2006).N. Nagaya, K. Kangawa, T. Itoh, et al.: Transplantation of mesenchymal stem cells improves cardiac function in a rat model of dilated cardiomyopathy, Circulation, 112, 1128-1135 (2005).Working Group for Autologous Cell Regenerative Treatment (ed.): “Jiko saibo saisei chiryo ho” hoseika no kangaekata (Thoughts on establishing the “Autologous Cell Regenerative Treatment Law,”) Tissue Engineering, 313-326, Nihon Igakukan (2007) (in Japanese).Received original manuscript April 14, 2008Revisions received June 2, 2008Accepted June 2, 2008AuthorHajime OhgushiGraduated from Nara Medical University in 1976. Received Doctor of Medicine (Biochemistry) at Graduate School, Nara Medical University in 1980. Worked at several hospitals as orthopedic surgeon. Worked as Research Associate at Case Western Reserve University of the United States in 1985-1987. After returning to Japan, started working on bone regeneration research using cell for clinical application. Joined the National Institute for Advanced Interdisciplinary Research (NAIR) as Chief Researcher in 2001. Also became Research Team Leader of the National Institute of Advanced Industrial Science in 2001. Became Senior Researcher of Research Institute for Cell Engineering in 2006. (5)−

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