Vol.1 No.3 2009

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Research paper−155 Synthesiology - English edition Vol.1 No.3 (2009) Regenerative medicine is a branch of medicine specializing in repairing and regenerating the functions of organs or tissues that were lost by disease or injury, through transplantation of cells or tissue derived from cells. Unlike conventional treatment, it involves the processes of growing (proliferation) and processing (differentiation) cells by engineering techniques for cultivation. Therefore, it is necessary to ensure safety in the processes of cell selection and cultivation. For example, for growing human (mammal) cells, cells are cultivated in culture medium containing various amino acids and vitamins. However, if the culture is contaminated by just one bacterium, since the growth rate of bacteria is several times faster than human cells, there will be far more bacteria by the time human cells have grown sufficiently. Infection may occur when such cultured cells are transplanted to the patient. To prevent such infection, cultivation must be conducted in strictly controlled, bacteria-free environment, or cell processing center (CPC) that specializes in growing human cell (Figure 1).1 IntroductionWith the recent advances in life science technology, application of advanced medical technology enables revolutionary treatment of diseases for which cure was not available. Advanced medical technology makes new treatment a reality even for serious disease where only option for cure was organ or tissue transplantation. For example, treatments for various intractable diseases are being attempted by regenerative medicine using cells. In regenerative medicine, harvested cells normally require the processes of growing (proliferation) and processing (differentiation) by culture. Needless to say, there must be no contamination by bacteria, mold, or virus in the culture process. Moreover, it is mandatory to ensure safety and efficacy of proliferated and differentiated cells in addition to preventing contamination. Various kinds of cells are used in regenerative medicine, and some are at the stage of practical use along with various risks, from basic research using ES cells to treatment using patient’s own somatic cells. Recently in news is the possibility of using induced pluripotent stem cells (iPS) developed by Professor Yamanaka et al of Kyoto University instead of ES cells which have ethical issues. However, currently both ES and iPS cells cause tumor called teratoma, and their safeties have not been established and therefore they cannot be used in actual treatment. Considering the above background, this paper reviews the issues in development of regenerative medical technology. Also, to promote early clinical application, we established a medical system for bone regeneration technology that can be readily accepted in the society. I shall describe our approach and results.2 Issues in the development of regenerative medical technology- Construction of human cell processing system in view of safety for the purpose of clinical application-Hajime OhgushiResearch Institute for Cell Engineering, AIST Nakoji 3-11-46, Amagasaki 661-0974, Japan E-mail : Recently, technology of regenerative medicine which utilizes cells after their proliferation and differentiation process has drawn attention. In order to utilize the technology for clinical application, safety issue of the process as well as usefulness of the cells should be confirmed. We analyzed the issues and succeeded in utilizing the cells after proliferation / differentiation process for the purpose of therapeutic applications.Development of regenerative medical technology working toward practical applicationKeywords : Regenerative medicine, cell culture (cell cultivation), cell differentiation, biomaterial, international standardFig. 1 From culture to transplantation of patient cell.[Translation from Synthesiology, Vol.1, No.3, p.170-175 (2008)](1)−Verification of biomaterial suitable for tissue-engineered boneInternational standardization(ISO TC150)Regulatory ScienceRegulations(Safety)(Efficacy)TransplantationPatientCellharvestingHospitalDifferentiation to osteoblast (production of tissue-engineered bone)Cell seedingProliferation of mesenchymal stem cells (MSC)Cell processing (removal of blood cells)Human cell processing center (CPC)Substrate (biomaterial)Cell selection and verificationContribution to society (treatment of disease)Type 2 Basic ResearchType 1 Basic Research Flow of cells used in regenerative medicine

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