International Journal of Stem Cells

Korean Society for Stem Cell Research (한국줄기세포학회)
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Guidelines for Manufacturing and Application of Organoids: Heart

  • Hyang-Ae Lee (Department of Predictive Toxicology, Korea Institute of Toxicology) ;
  • Dong-Hun Woo (Organoid Standards Initiative ) ;
  • Do-Sun Lim (Organoid Standards Initiative ) ;
  • Jisun Oh (Organoid Standards Initiative ) ;
  • C-Yoon Kim (Organoid Standards Initiative ) ;
  • Ok-Nam Bae (Organoid Standards Initiative ) ;
  • Sun-Ju Ahn (Organoid Standards Initiative )
  • Received : 2024.04.08
  • Accepted : 2024.05.13
  • Published : 2024.05.30
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Abstract

Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.

Keywords

Acknowledgement

This work was supported by a grant (23212MFDS265) from the Ministry of Food and Drug Safety in 2023 and the National Research Foundation grant funded by the Ministry of Science and ICT of Korea (RS-2023-00225239).

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