Department of Experimental Biology, Faculty of Science, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.
International Clinical Research Center, St. Anne's University Hospital Brno, Pekařská 53, 656 91 Brno, Czech Republic.
Int J Mol Sci. 2020 Mar 31;21(7):2435. doi: 10.3390/ijms21072435.
Human pluripotent stem cells have the potential to change the way in which human diseases are cured. Clinical-grade human embryonic stem cells and human induced pluripotent stem cells have to be created according to current good manufacturing practices and regulations. Quality and safety must be of the highest importance when humans' lives are at stake. With the rising number of clinical trials, there is a need for a consensus on hPSCs characterization. Here, we summarize mandatory and 'for information only' characterization methods with release criteria for the establishment of clinical-grade hPSC lines.
人类多能干细胞有可能改变人类疾病的治疗方式。根据现行的良好生产规范和法规，必须创建临床级别的人类胚胎干细胞和人类诱导多能干细胞。当涉及到人类的生命时，质量和安全必须是最重要的。随着临床试验数量的增加，需要就 hPSC 的特征达成共识。在这里，我们总结了强制性和“仅供参考”的特征分析方法以及建立临床级 hPSC 系的放行标准。
