《生命科学》 2016, 28(7): 731-742

临床研究用人胚胎干细胞“种子细胞”的质量评价

纳　涛1#，郝　捷2#，张可华1，王　娟2，王　柳2，王军志1，周　琪2*，袁宝珠1*

(1 中国食品药品检定研究院细胞资源保藏研究中心，北京 100050；2 中国科学院动物研究所计划生育生殖生物学国家重点实验室，北京 100101)

摘　要：摘　要：人胚胎干细胞(human embryonic stem cells， hESCs) 具有自我更新和三胚层细胞分化的潜能，在特定代次处于未分化状态的hESCs 可作为“种子细胞”，在体外诱导分化成不同的功能细胞以适用于不同的临床适应症。为确保hESCs 诱导分化的功能细胞在临床应用的安全性及有效性，hESCs 作为“种子细胞”需具备明确的鉴别特征、多能性、分化潜能和微生物学安全性等质量属性，现就这些质量属性进行讨论，目的是为在我国建立hESCs“种子细胞”质量控制标准提供参考。

Quality assessment of ‘seed cells’ of human embryonic stem cells to be used in clinical studies

NA Tao1#， HAO Jie2#， ZHANG Ke-Hua1， WANG Juan2， WANG Liu2，WANG Jun-Zhi1， ZHOU Qi2* ， YUAN Bao-Zhu1*

(1 Cell Collection and Research Center， National Institutes for Food and Drug Control， Beijing 100050， China; 2 State Key Laboratory of Reproductive Biology， Institute of Zoology， Chinese Academy of Sciences， Beijing 100101， China)

Abstract: Abstract: Human embryonic stem cells (hESCs) can proliferate without limit and differentiate into almost all cell lineages of three germ layers in vitro， thus holding tremendous potentials in developing stem cell-based medicinal products. Currently， the hESCs maintaining undifferentiated with complete differentiation potentials within certain propagation passage is regarded as ‘seed cells’， which are used as starting material in the induced differentiation into various terminal function cells or progenitors of the function cells according to different clinical indications. Thus， to ensure the success of induced differentiation， safety， and effectiveness in clinical applications， the ‘seed
    cells’ must not only exhibit unambiguous cell identity， ‘stemness’ and full differentiation potential， but also be free from microbiological contamination during the entire preparation process. All of these in fact represent the key quality attributes of the ‘seed cells’， and should be comprehensively assessed in the quality control tests during， or at the end of， the ‘seed cell’ preparation. In this paper， with our own experiences in quality assessment of hESC‘seed cells’， we discussed the key quality attributes of the ‘seed cells’as well as the proposed standards of each attribute with a goal of establishing a comprehensive quality assessment system for hESC ‘seed cells’in China.