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Expert Opin Drug Metab Toxicol. 2012 Feb;8(2):239-57. doi: 10.1517/17425255.2012.639763. Epub 2012 Jan 17.

Standardization of pluripotent stem cell cultures for toxicity testing.

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Institute for Health & Consumer Protection, Systems Toxicology Unit, Joint Research Centre, European Commission, Ispra, Italy.



Pluripotent stem cell (PSC) lines offer a unique opportunity to derive various human cell types that can be exploited for human safety assessments in vitro and as such contribute to modern mechanistically oriented toxicity testing.


This article reviews the two major types of PSC cultures that are currently most promising for toxicological applications: human embryonic stem cell lines and human induced PSC lines. Through the review, the article explains how these cell types will improve the current safety evaluations of chemicals and will allow a more efficient selection of drug candidates. Additionally, the article discusses the important issues of maintaining PSCs as well as their differentiation efficiency.


The demonstration of the reliability and relevance of in vitro toxicity tests for a given purpose is mandatory for their use in regulatory toxicity testing. Given the peculiar nature of PSCs, a high level of standardization of undifferentiated cell cultures as well as of the differentiation process is required in order to ensure the establishment of robust test systems. It is, therefore, of pivotal importance to define and internationally agree on crucial parameters to judge the quality of the cellular models before enrolling them for toxicity testing.

[Indexed for MEDLINE]

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