PMID: 24340665Dec 18, 2013Paper

Regulatory science research to facilitate the development of cell/tissue-processed products

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyūjo hōkoku = Bulletin of National Institute of Health Sciences
Yoji SatoSatoshi Yasuda

Abstract

Regenerative medicine is regarded as innovative therapy for severe diseases and damages caused by tissue loss and functional impairment. In Japan, regenerative medicine is one of the most important subjects issued by Council for Science and Technology Policy and also referred to in Medical Innovation of New Growth Strategy. Cell/tissue-processed products are living cells, which have been manipulated or processed for the purpose of regenerative medicine, and are extensively developing. Human somatic cells, somatic stem cells, embryonic stem cells, and induced pluripotent stem cells are cell sources used for regenerative medicine. Since we lack in experiences with cell/tissue-processed products, technical development of safety and quality assessment is urgently needed. National Institute of Health Sciences has carried out a mission of Regulatory Science and worked on safety assessment of pharmaceuticals and medical devices and their guideline development. The objective of our study is to develop safety and quality assessment methods for cell/tissue-processed products derived from stem cells, based on recent progresses in life science. We are currently developing methods to evaluate products as follows; a) useful and quantitative ...Continue Reading

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