Fraser Lindsay, Bruce Kevin, Campbell John M, De Sousa Paul A
RoslinCT, NINE Edinburgh Bioquarter, Edinburgh, UK.
Censo Biotechnologies, Roslin Biocentre, Roslin, Midlothian, UK.
Methods Mol Biol. 2018;1780:607-629. doi: 10.1007/978-1-4939-7825-0_28.
Cell transplantation therapy aspires to repair and restore lost function while minimizing the risk of harm. The potential for harm arises from cell instability, variability, inappropriate behavior, and/or transmission of adventitious pathogens. Quality assured and controlled assessment and production of human cells for clinical use ensures that the risk of harm is minimized. Application of quality standards requires thorough planning and consultation with regulatory authorities on process and product specifications, as early as possible at the research and development (R&D) stage. Here we outline considerations applicable to all human cells in relation to regulatory governance, the route to the clinic and Cell Therapy Product (CTP) characterization, with special emphasis on human pluripotent stem cells (hPSC).
细胞移植疗法旨在修复和恢复丧失的功能，同时将伤害风险降至最低。伤害风险源于细胞的不稳定性、变异性、不当行为和/或外来病原体的传播。对用于临床的人类细胞进行质量保证和控制的评估与生产，可确保将伤害风险降至最低。应用质量标准需要进行全面规划，并尽早在研发阶段就过程和产品规格与监管机构进行磋商。在此，我们概述了适用于所有人类细胞的监管治理、临床应用途径和细胞治疗产品特性等方面需要考虑的因素，特别强调了人类多能干细胞。
