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Updated: Aug 7, 2025

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
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Developmental Toxicity Studies: The Path towards Humanized 3D Stem Cell-Based Models.

Mariana A Branco1,2,3, Tiago C Nunes2,3, Joaquim M S Cabral2,3

  • 1Collaborative Laboratory to Foster Translation and Drug Discovery, Accelbio, 3030-197 Cantanhede, Portugal.

International Journal of Molecular Sciences
|March 11, 2023
PubMed
Summary
This summary is machine-generated.

Humanized in vitro models using stem cells offer a promising alternative to animal testing for assessing drug safety during pregnancy. These models improve the prediction of human developmental toxicity, addressing critical data gaps for medications used by pregnant women.

Keywords:
developmental toxicityhuman gastruloidshuman heart organoidshuman stem cell-based teratogenic modelsin vitro human teratogenicity

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Area of Science:

  • Developmental toxicology
  • Stem cell biology
  • Pharmacology

Background:

  • Increasing drug prescriptions for pregnant women necessitate accurate teratogenicity data.
  • Existing animal models have limitations in predicting human-specific drug developmental toxicity.
  • Gaps in human teratogenic risk information for many medications pose a significant challenge.

Purpose of the Study:

  • To review the development and application of human pluripotent stem cell-derived models for developmental toxicity testing.
  • To highlight the potential of in vitro humanized models to overcome limitations of animal studies.
  • To emphasize models recapitulating key early human developmental stages like gastrulation and cardiac specification.

Main Methods:

  • Utilizing human pluripotent stem cells (hPSCs) to create in vitro models.
  • Developing models that mimic early human embryonic development, including gastrulation and cardiac specification.
  • Assessing the utility of these models in developmental toxicity studies.

Main Results:

  • Humanized in vitro models provide physiologically relevant data for human developmental toxicity.
  • These models show promise in accurately identifying teratogenic risks, surpassing inter-species extrapolation issues.
  • Specific models focusing on gastrulation and cardiac specification stages demonstrate high relevance for early developmental toxicity assessment.

Conclusions:

  • Human pluripotent stem cell-derived models represent a significant advancement in developmental toxicity testing.
  • These in vitro humanized systems are crucial for improving the safety assessment of drugs during pregnancy.
  • The application of these models can lead to more reliable predictions of human teratogenicity, enhancing drug safety for expectant mothers.