中文摘要：

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。

英文摘要：

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.