Citation:

Piersma, A., Nancy C. Baker, G. Daston, B. Flick, M. Fujiwara, T. Knudsen, H. Spielmann, N. Suzuki, K. Tsaioun, AND H. Kojima. Pluripotent Stem Cell Assays: Modalities and Applications for Predictive Developmental Toxicity. Current Research in Toxicology. Elsevier B.V., Amsterdam, Netherlands, 3:100074, (2022). https://doi.org/10.1016/j.crtox.2022.100074

Impact/Purpose:

Report of an expert group assembeled to develop a detailed review paper on the historical development, application and performance of pluripotent stem cell models for predictive developmental toxicity. The protocol used a systematic scoping review of available models to identify a corpus of 1533 PubMed records (circa 1991-2021). These were reduced to 192 papers by AI and manual curation, to identify 18 papers that tested 10 or more annotated chemicals and 174 papers used for evidentiary support.  

Description:

This manuscript provides a review focused on embryonic stem cell-based models and their place within the landscape of alternative developmental toxicity assays. Against the background of the principles of developmental toxicology, the wide diversity of alternative methods using pluripotent stem cells developed in this area over the past half century is reviewed. In order to provide an overview of available models, a systematic scoping review was conducted following a published protocol with inclusion criteria, which were applied to select the assays. Critical aspects including biological domain, readout endpoint, availability of standardized protocols, chemical domain, reproducibility and predictive power of each assay are described in detail, in order to review the applicability and limitations of the platform in general and progress moving forward to implementation. The horizon of innovative routes of promoting regulatory implementation of alternative methods is scanned, and recommendations for further work are given.

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