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2020 - Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations

CiPA review in Regulatory Toxicology and Pharmacology (2020)

Authors:
Gintant G., Kaushik E.P., Feaster T., Stoelzle-Feix S., Kanda Y., Osada T., Smith G., Czysz K., Kettenhofen R., Rong Lu H., Cai B., Shi H., Herron T.J., Dang Q., Burton F., Pang L., Traebert M., Abassi Y., Beck Pierson J., Blinova K.

Journal:
Regulatory Toxicology and Pharmacology (2020) doi: 10.1016/j.yrtph.2020.104756


Abstract:

Human stem cell-derived cardiomyocytes (hSC-CMs) hold great promise as in vitro models to study the elec-trophysiological effects of novel drug candidates on human ventricular repolarization. Two recent large vali-dation studies have demonstrated the ability of hSC-CMs to detect drug-induced delayed repolarization and “cellrhythmias” (interrupted repolarization or irregular spontaneous beating of myocytes) linked to Torsade-de- Pointes proarrhythmic risk. These (and other) studies have also revealed variability of electrophysiological re-sponses attributable to differences in experimental approaches and experimenter, protocols, technology plat-forms used, and pharmacologic sensitivity of different human-derived models. Thus, when evaluating drug- induced repolarization effects, there is a need to consider 1) the advantages and disadvantages of different approaches, 2) the need for robust functional characterization of hSC-CM preparations to define “fit for purpose” applications, and 3) adopting standardized best practices to guide future studies with evolving hSC-CM prepa-rations. Examples provided and suggested best practices are instructional in defining consistent, reproducible, and interpretable “fit for purpose” hSC-CM-based applications. Implementation of best practices should enhance the clinical translation of hSC-CM-based cell and tissue preparations in drug safety evaluations and support their growing role in regulatory filings.


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