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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 autologous 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 autologous human somatic stem cells

机译：确保自体人类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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To make sure that novel human cell-based products contribute to human health care, it is essential that, based on sound science at present, suitable measures be taken by the manufacturers and regulatory authorities on applying these products to the treatment of patients by taking into account specificity of starting cell lines, the manufacturing process, products, administration procedures, diseases in question, and patient population. As part of such an endeavor, we studied scientific principles, concepts, and basic technical elements to ensure the quality and safety of therapeutic products derived from autologous 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. 0907-2, ''Guideline on Ensuring the Quality and Safety of Pharmaceuticals and Medical Devices Derived from the Processing of Autologous 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 the development of our study and the resulting guidance. For products derived from autologous somatic stem cells, major points to consider include 1) multipotency and self-replication ability of autologous human somatic stem cells and differences in cell characteristics of the final products from those of the starting cells; 2) a donor's infectious status; 3) the risk of proliferation/reactivation of viruses during the manufacturing processes; 4) robust process control to minimize unevenness of ''custom-made'' products; 5) a limited amount of samples for quality evaluation of products; and 6) 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 functions. The ultimate goal of this guidance is to provide suitable medical opportunities as soon as possible to the patients.
机译：为了确保新的基于人体细胞的产品有助于人类健康，目前，基于可靠的科学，制造商和监管机构必须采取适当措施，将这些产品应用于患者的治疗，这一点非常重要。说明起始细胞系的特异性，生产过程，产品，给药程序，所讨论的疾病和患者群体。作为这项工作的一部分，我们研究了科学原理，概念和基本技术要素，以确保自体人类体干细胞衍生的治疗产品的质量和安全性，同时考虑到科学技术的进步，道德规范，监管原理和国际标准。人类干细胞衍生产品的趋势。这就导致了日本药品和食品安全局发布的第0907-2号日本官方通知“确保自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指南”日本厚生劳动省，2012年9月7日。本文介绍了背景信息，研究的进展以及由此产生的指导。对于自体体干细胞衍生的产品，需要考虑的主要问题包括：1）自体人体干细胞的多能性和自我复制能力以及最终产品与起始细胞的细胞特性差异; 2）捐赠者的传染状况; 3）在制造过程中病毒增殖/再激活的风险; 4）强大的过程控制，以最大程度地减少“定制”产品的不均匀性; 5）用于产品质量评估的样品数量有限; 6）最终产品在不同于原始细胞定位并正在发挥其天然内源功能的细胞环境中的稳健应用和功能。本指南的最终目标是尽快为患者提供适当的医疗机会。

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