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获得CiPA资格的人类iPSC衍生的心肌细胞:通过评估药物诱导的心律失常症,在毒性测试中的新前沿

Vijay Bhaskar Reddy Konala¹, Rutuja Kuhikar¹, Shruti More¹

¹Department of Integrated Drug Discovery and Development, C113, Yashraj Biotechnology Ltd, TTC Industrial Area MIDC, Pawnae, Navi Mumbai 400705, Maharastra, India.

Toxicology in vitro : an international journal published in association with BIBRA

|June 7, 2025

概括

人类诱导的多能干细胞衍生心肌细胞 (hiPSC-CMs) 有效地预测药物诱导的心律失常. 这项研究验证了YBLiCardio细胞用于心脏安全评估,增强临床前药物开发和患者安全.

科学领域:

心血管药理学心血管药理学
干细胞生物学干细胞生物学
药物安全评估药物安全评估

背景情况:

药物诱导的心律失常在药物开发过程中存在重大风险,导致药物退出市场.
综合性体外前节律检测 (CiPA) 计划旨在利用人类诱导的多能干细胞衍生心肌细胞 (hiPSC-CMs) 改进心脏安全测试.

研究的目的:

评估28种药物的前节律潜力,使用一个具有良好的特征的hiPSC-CM模型 (YBLiCardio).
评估电场潜力 (EFP) 测量在CiPA框架内对心脏安全评估的有用性.

主要方法:

使用了YBLiCardio细胞和CardioExcyte 96系统进行电场潜力 (EFP) 测量.
在四种度中测试了28种药物,分析了动态节拍模式的变化和QT延长.
结果与现有的HESI CiPA研究结果和文献进行了比较.

主要成果:

YBLiCardio细胞对所有测试药物表现出一致的反应,与HESI CiPA研究结果一致.
确定了多佩里和多佩里是高风险化合物,与之前的研究一致.
显示了对 хлорпромазин 的增强预测准确性,表明了模型的灵敏度.

结论:

hiPSC-CMs,特别是YBLiCardio,为药物开发中的前节律失常风险评估提供了一个强大的平台.
该模型补充了离子通道测定和in silico方法,支持更安全的临床前药物发现.
YBLiCardio促进了生理学上相关的心脏毒性预测,有助于有效的药物开发.

关键词:

有急性毒性的急性毒性.心脏有毒性 - 心脏有毒性慢性毒性慢性毒性这就是CiPA CiPA.药物诱导的心律不整.电力生理学电力生理学临床前测定临床前测定在 YBLi 卡迪奥这就是hiPSC-CMs.

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