Development of Innovative in Vitro Test Protocol for Human Embryotoxicity

Abstract

The influence of the reproduction and generating on the man of a biomaterial is still unknown. Spielmann et al. developed the embryonic stem cell test (EST), which is an in vitro embryotoxicity test method that can be used to estimate the risk of embryotoxicity of chemical substances relatively quickly compared to the conventional methods that involve animal experiments. The EST has been evaluated in a validation study by the European Centre for the Validation of Alternative Methods: ECVAM in which two other in vitro embryotoxicity tests (micromass test, whole embryo culture test) were validated against a set of test chemicals characterized by high levels of in vivo embryotoxicity data in laboratory animals and humans. In a validation study in Europe, the EST was found to be reproducible, demonstrating an overall accuracy of 80% and 100% correct prediction of strong embryotoxicity. In EST original protocol, there are some points involving the chemical characteristics of biomaterials that could be improved. Near future, we will release the 4-dimensional experimental model into which it was made to development.