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Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice

Gary Gintant1, Emily Pfeiffer Kaushik2, Tromondae Feaster3

  • 1Department of Integrative Pharmacology, Integrated Sciences and Technology, AbbVie, North Chicago, IL, 60064, USA.

Regulatory Toxicology and Pharmacology : RTP
|August 22, 2020
PubMed
Summary

Human stem cell-derived cardiomyocytes (hSC-CMs) show promise for drug testing. Standardizing protocols and characterizing hSC-CMs ensures reliable results for drug safety evaluations.

Keywords:
CardiotoxicityCardiovascular safety assessmentCellrhythmiasCiPADelayed repolarizationJiCSANonclinical safetyProarrhythmic risk assessmentSafety pharmacologyhSC-CM

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Area of Science:

  • Cardiology
  • Pharmacology
  • Biotechnology

Background:

  • Human stem cell-derived cardiomyocytes (hSC-CMs) are valuable in vitro models for assessing drug effects on cardiac repolarization.
  • Previous studies confirm hSC-CMs can detect drug-induced repolarization abnormalities and proarrhythmic risks like Torsade-de-Pointes.
  • Variability in hSC-CM responses necessitates careful consideration of experimental factors.

Purpose of the Study:

  • To highlight the need for standardized best practices in utilizing hSC-CMs for drug safety evaluations.
  • To guide the robust functional characterization of hSC-CM preparations for specific applications.
  • To improve the consistency, reproducibility, and interpretability of hSC-CM-based drug testing.

Main Methods:

  • Review of recent validation studies on hSC-CMs for drug-induced repolarization assessment.
  • Analysis of factors contributing to variability in hSC-CM electrophysiological responses.
  • Development of suggested best practices for hSC-CM application and characterization.

Main Results:

  • hSC-CMs effectively identify drug-induced delayed repolarization and "cellrhythmias" linked to proarrhythmic risk.
  • Significant variability exists in hSC-CM responses due to differences in experimental protocols, platforms, and model sensitivity.
  • Standardized characterization and best practices are crucial for reliable drug safety assessments.

Conclusions:

  • Adopting standardized best practices and robust functional characterization is essential for optimizing hSC-CM applications in drug development.
  • Implementation of these practices will enhance the clinical translation and regulatory acceptance of hSC-CM-based assays.
  • Consistent and reproducible hSC-CM assays will improve the prediction of drug-induced cardiac risks.