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首页> 外文期刊>Regenerative Therapy >A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of allogeneic human somatic stem cells
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A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of allogeneic human somatic stem cells

机译：确保同种异体人体干细胞加工产生的药品和医疗器械的质量和安全性的研究

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As a series of endeavors to establish suitable measures for the sound development of regenerative medicine using human stem cell-based products, we studied scientific principles, concepts, and basic technical elements to ensure the quality and safety of therapeutic products derived from allogeneic human somatic stem cells, taking into consideration scientific and technological advances, ethics, regulatory rationale, and international trends in human stem cell-derived products. This led to the development of the Japanese official Notification No. 0907-3, ''Guideline on Ensuring the Quality and Safety of Pharmaceuticals and Medical Devices Derived from the Processing of Allogeneic Human Somatic Stem Cells,'' issued by Pharmaceuticals and Food Safety Bureau, Ministry of Health, Labour and Welfare of Japan, on September 7, 2012. The present paper describes the background information and development of our study and the resulting guidance. For products derived from allogeneic somatic stem cells, major points to consider include 1) history, the source, and derivation of starting cells; 2) donor screening/testing and donor eligibility, especially in relation to the presence of adventitious agents, potential occurrence of donor-derived diseases, and immunocompatibility; 3) clinical records of a donor; 4) multipotency and self-replication ability of allogeneic human somatic stem cells; 5) cell banking; 6) potential presence of viruses in the final product; 7) extensive characterization of the cells at critical stage(s) of manufacture; 8) robustness of the manufacturing process; 9) quality consistency of the products such as the final products and critical intermediate(s) if any; and 10) robust application and function of the final products in a cell environment different from where the original cells were localized and were performing their natural endogenous function. The ultimate goal of this guidance is to provide suitable medical opportunities as soon as possible to the patients with severe diseases that are difficult to treat with conventional modalities.
机译：为了建立一系列合理的措施，以使用人类干细胞为基础的产品来促进再生医学的健康发展，我们研究了科学原理，概念和基本技术要素，以确保来源于异体人类体细胞干的治疗产品的质量和安全性。细胞，并考虑到人类干细胞衍生产品的科学技术进步，道德规范，管理依据和国际趋势。这就导致了日本药品和食品安全局发布的第0907-3号日本官方通知“确保从异体人类干细胞加工中获得的药品和医疗器械的质量和安全性指南”日本厚生劳动省，2012年9月7日。本文描述了本研究的背景信息和发展以及所产生的指导。对于来自异体体干细胞的产品，需要考虑的重点包括：1）历史，起始细胞的来源和来源; 2）供体的筛查/测试和供体的资格，尤其是与不定因素的存在，供体来源的疾病的潜在发生以及免疫相容性有关; 3）供体的临床记录; 4）同种异体人体干细胞的多能性和自我复制能力; 5）手机银行; 6）最终产品中可能存在病毒; 7）在制造的关键阶段对电池进行广泛的表征; 8）制造过程的稳健性; 9）产品（例如最终产品和关键中间体）的质量一致性; 10）最终产品在不同于原始细胞定位并发挥其天然内源功能的细胞环境中的稳健应用和功能。该指南的最终目标是尽快为患有传统疾病难以治疗的严重疾病患者提供合适的医疗机会。

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