European Commission, Joint Research Centre, Ispra, Italy.
Centre for Predictive Human Model Systems, Atal Incubation Centre-Centre for Cellular and Molecular Biology, Hyderabad, India.
Reprod Toxicol. 2022 Sep;112:36-50. doi: 10.1016/j.reprotox.2022.06.003. Epub 2022 Jun 11.
The advent of the technology to isolate or generate human pluripotent stem cells provided the potential to develop a wide range of human models that could enhance understanding of mechanisms underlying human development and disease. These systems are now beginning to mature and provide the basis for the development of in vitro assays suitable to understand the biological processes involved in the multi-organ systems of the human body, and will improve strategies for diagnosis, prevention, therapies and precision medicine. Induced pluripotent stem cell lines are prone to phenotypic and genotypic changes and donor/clone dependent variability, which means that it is important to identify the most appropriate characterization markers and quality control measures when sourcing new cell lines and assessing differentiated cell and tissue culture preparations for experimental work. This paper considers those core quality control measures for human pluripotent stem cell lines and evaluates the state of play in the development of key functional markers for their differentiated cell derivatives to promote assurance of reproducibility of scientific data derived from pluripotent stem cell-based systems.
人类多能干细胞分离或生成技术的出现，为开发广泛的人类模型提供了可能，这些模型可以增强对人类发育和疾病机制的理解。这些系统现在开始成熟，并为开发体外分析方法提供了基础，这些方法可以理解涉及人体多器官系统的生物学过程，并将改进诊断、预防、治疗和精准医学的策略。诱导多能干细胞系容易发生表型和基因型变化以及供体/克隆依赖性变异性，这意味着在获取新细胞系和评估用于实验工作的分化细胞和组织培养物时，确定最合适的特征标志物和质量控制措施非常重要。本文考虑了人类多能干细胞系的核心质量控制措施，并评估了关键功能标志物的开发现状，这些标志物用于其分化细胞衍生物，以促进基于多能干细胞系统的科学数据可重复性的保证。
