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Related Concept Videos

Preclinical Development: Overview01:28

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Mice have long served as models for studying human biology and pathology because of their phylogenetic and physiological similarity with humans. They are also easy to maintain and breed in the laboratory, and hence, many inbred strains are now available for research. Studies on mice have contributed immeasurably to our understanding of cancer biology.
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Updated: Jan 14, 2026

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Development of Animal Models for Preclinical Safety Studies.

Takako Yamamoto1, Masayuki Shikamura2, Glyn N Stacey3,4

  • 1Department of Science, Technology and Innovation, Kobe University, Kobe, Japan.

Advances in Experimental Medicine and Biology
|October 24, 2025
PubMed
Summary

Tumorigenicity testing is crucial for pluripotent stem cell (PSC) therapies to ensure safety. This involves careful design considerations for in vivo studies to assess the risk of undifferentiated cell proliferation after transplantation.

Keywords:
129 mouseB6 mouseCNVExtrapolabilityGene instabilityNOD-SCID mouseNOG mousePSCSNVSafety testTPD50Tumorigenicity testWGSWHO TSR 878iPSC

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Area of Science:

  • Stem Cell Biology
  • Regenerative Medicine
  • Toxicology

Background:

  • Pluripotent stem cell (PSC) therapies face safety concerns regarding tumor formation from undifferentiated cells.
  • Genetic or epigenetic changes during prolonged culture can lead to differentiation resistance and potential tumorigenicity.
  • For induced PSCs (iPSCs), partial reprogramming and epigenetic memory pose unique challenges.

Purpose of the Study:

  • To provide guidance on designing robust tumorigenicity tests for PSC-based products.
  • To address critical factors in risk assessment for in vivo safety evaluations.
  • To ensure the safe translation of PSC therapies into clinical applications.

Main Methods:

  • Discussion of key parameters for designing tumorigenicity assays.
  • Considerations include selection of immunodeficient rodent models.
  • Statistical requirements for group sizes, cell doses, positive controls, monitoring, and result interpretation are discussed.

Main Results:

  • The chapter outlines essential elements for a well-designed tumorigenicity test.
  • It emphasizes a risk-based approach to assay development.
  • Highlights the necessity of linking pre-clinical safety data to clinical outcomes.

Conclusions:

  • Rigorous tumorigenicity testing is indispensable for PSC-based cell therapies, particularly for first-in-human studies.
  • Proper assay design, informed by risk assessment, is critical for ensuring patient safety.
  • Further research is needed to correlate pre-clinical findings with in vivo behavior in the transplanted tissue microenvironment.