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The preclinical evaluation of human pluripotent stem cells (hPSCs) products is a complex and crucial process, in which the use of animal models plays a pivotal position. Animal models are diverse, possess unique research value and applicability, and can provide abundant data to support the preclinical evaluation of stem cell products. When selecting animal models, various factors need to be considered comprehensively. The models should exhibit similarities to human diseases in terms of anatomical structure, physiological and biochemical characteristics, and pathological features to better simulate stem cell behavior in the human body. The choice of models also needs to consider experimental objectives, the characteristics of stem cell products, and animal welfare and ethical principles. Finally, this review introduces some examples of preclinical evaluation of hPSCs products in animal disease models, including acute lung injury, acute liver failure, Parkinson’s disease, Alzheimer’s disease, osteoarthritis, membranous nephropathy, corneal alkali damage, and intrauterine adhesions.

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Development of Animal Models for Preclinical Testing of hPSCs Products

  • 章节

  • 发表日期：

    2025年

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  • Zhongwen Li,
  • Lingxue Xu,
  • Faguo Sun,
  • Wumei Wei,
  • Shasha Liu,
  • Haoyuan Wang,
  • Qun Ma,
  • Wanren Zhang,
  • Ying Zhang,
  • Wei Li,
  • Jun Wu

摘要

The preclinical evaluation of human pluripotent stem cells (hPSCs) products is a complex and crucial process, in which the use of animal models plays a pivotal position. Animal models are diverse, possess unique research value and applicability, and can provide abundant data to support the preclinical evaluation of stem cell products. When selecting animal models, various factors need to be considered comprehensively. The models should exhibit similarities to human diseases in terms of anatomical structure, physiological and biochemical characteristics, and pathological features to better simulate stem cell behavior in the human body. The choice of models also needs to consider experimental objectives, the characteristics of stem cell products, and animal welfare and ethical principles. Finally, this review introduces some examples of preclinical evaluation of hPSCs products in animal disease models, including acute lung injury, acute liver failure, Parkinson’s disease, Alzheimer’s disease, osteoarthritis, membranous nephropathy, corneal alkali damage, and intrauterine adhesions.