基于人胚胎干细胞健康安全评价体系的构建

食品、药品、医疗器械和材料、生物制剂以及环境的质量和健康安全是政府和民众十分关注的热点问题。目前国际标准的健康安全评价检测方法以微生物、动物及其细胞作为载体，不能准确反映人类的生物学特征，预测人体心、肝等靶器官毒性及发育毒性的准确率偏低，在技术层面严重制约了人类健康安全的评价和监控。如何建立准确反映人类生物学特征的健康安全评价体系是关系国民健康安全的重大科学问题［1］。人类胚胎干细胞（human embryonic stem cells, hESCs）可真实反映人类生物学特征，并利用其无限增殖和定向分化的特点，可达到检测载体的高度标准化，hESCs技术的发展为体外健康安全评价体系的升级提供了有力支持。由北京大学牵头，联合浙江大学、中国医学科学院整形外科医院和军事医学科学院，与新加坡国立大学合作，我们完成了科技部国际科技合作一期项目“基于人胚胎干细胞健康安全评价新载体的构建”，并就相关研究成果作为科研工作综述进行发表［2］。在此基础上，合作团队顺利完成了二期项目“创建人胚胎干细胞健康安全预测新体系”，取得了系列成果，现综述如下。

Development of human embryonic stem cell platforms for human health-safety evaluation

SUMMARY Thehumanembryonicstemcells(hESCs)serveasaself-renewable,genetically-healthy, pluripotent and single source of all body cells,tissues and organs.Therefore,it is considered as the good standard for all human stem cells by US,Europe and international authorities.In this study,the standard and healthy human mesenchymal progenitors,ligament tissues,cardiomyocytes,keratinocytes,primary neurons,fibroblasts,and salivary serous cells were differentiated from hESCs.The human cellular health-safety of NaF,retinoic acid,5-fluorouracil,dexamethasone,penicillin G,adriamycin,lead ace-tate PbAc,bisphenol A-biglycidyl methacrylate (Bis-GMA)were evaluated selectively on the standar-dized platforms of hESCs,hESCs-derived cardiomyocytes,keratinocytes,primary neurons,and fibro-blasts.The evaluations were compared with those on the currently most adopted cellular platforms.Parti-cularly,the sensitivity difference of PM2.5 toxicity on standardized and healthy hESCs derived fibroblasts, currently adopted immortalized human bronchial epithelial cells Beas-2B and human umbilical vein endo-thelial cells (HUVECs)were evaluated.The results showed that the standardized hESCs cellular plat-forms provided more sensitivity and accuracy for human cellular health-safety evaluation.