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Related Experiment Video

Updated: Dec 2, 2025

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
05:45

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

303

Focus on germ-layer markers: A human stem cell-based model for in vitro teratogenicity testing.

Manuela Jaklin1, Jitao David Zhang2, Paul Barrow2

  • 1Pharmaceutical Sciences, F. Hoffmann-La Roche, Pharma Research and Early Development, Roche Innovation Center Basel, Switzerland; Department for In Vitro Toxicology and Biomedicine Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Germany.

Reproductive Toxicology (Elmsford, N.Y.)
|November 4, 2020
PubMed
Summary

This study developed a human induced pluripotent stem cell (hiPSC) assay to predict drug teratogenicity. The assay monitors gene expression changes, identifying potential predictive markers for developmental toxicity.

Keywords:
Embryoid bodiesGene egulationHuman induced pluripotent stem cellsScorecardTeratogenicity

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Area of Science:

  • Stem cell biology
  • Toxicology
  • Drug development

Background:

  • Teratogenicity testing is crucial for drug safety.
  • Current methods, like the murine embryonic stem cell test (EST), have limitations.
  • Human induced pluripotent stem cells (hiPSCs) offer a promising alternative for in vitro toxicity screening.

Purpose of the Study:

  • To develop and validate a human cell-based assay for predicting drug teratogenicity using hiPSCs.
  • To identify early developmental genes as potential biomarkers for teratogenic effects.
  • To establish a foundation for replacing animal testing in teratogenicity screening.

Main Methods:

  • Utilized a human pluripotent stem cell scorecard panel to monitor 96 marker genes.
  • Employed embryoid body formation from a selected hiPSC line for the assay.
  • Tested assay performance with eight reference compounds in concentration-response and time-course experiments.
  • Applied data analysis and machine learning to identify predictive markers.

Main Results:

  • The hiPSC assay demonstrated technical performance and readout stability.
  • Each reference compound exhibited distinct effects on marker gene expression.
  • Identified 19 out of 96 genes as potential predictive markers for teratogenicity.
  • Preliminary machine-learning models showed promise for assay development.

Conclusions:

  • The developed hiPSC assay is suitable for pre-screening pharmaceutical compounds for teratogenicity.
  • This human cell-based approach could potentially replace the murine EST.
  • The assay provides a pathway towards more predictive and ethical drug safety assessments.