Comprehensive Translational Assessment of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias

Toxicological Sciences - Tập 155 Số 1 - Trang 234-247 - 2017
Ksenia Blinova1, Jayna Stohlman1, José Vicente2,1,3, Dulciana Chan1, Lars Johannesen1, María P. Hortigón-Vinagre4,5, Víctor Zamora4,5, Godfrey L. Smith4,5, William Crumb6, Li Pang7, Beverly Lyn‐Cook7, Jonathan Ross8, Mathew Brock8, Stacie A. Chvatal8, Daniel C. Millard8, Loriano Galeotti1, Norman Stockbridge3, David G. Strauss1,9
1US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, Maryland
2BSICoS Group, Aragón Institute for Engineering Research (I3A), IIS Aragón, University of Zaragoza, Zaragoza, Spain
3US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, Maryland
4Clyde Biosciences, Glasgow, UK
5University of Glasgow, Glasgow, UK
6Zenas Technologies, Metairie, Louisiana
7Division of Biochemical Toxicology, US Food and Drug Administration, National Center for Toxicological Research, Jefferson, Arkansas
8Axion BioSystems, Atlanta, Georgia
9US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Clinical Pharmacology, Silver Spring, Maryland

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2005, International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice, Fed. Regist, 70, 61134

2005, International Conference on Harmonisation; guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; availability. Notice, Fed. Regist, 70, 61133

10.1161/01.CIR.0000139333.83620.5D

Asakura, 2015, Improvement of acquisition and analysis methods in multi-electrode array experiments with iPS cell-derived cardiomyocytes, J Pharmacol. Toxicol. Methods, 75, 17, 10.1016/j.vascn.2015.04.002

10.1016/j.stem.2011.12.013

10.1001/jama.291.3.309

10.1093/toxsci/kfu084

Colatsky T. Fermini B. Gintant G. Pierson J. B. Sager P. Sekino Y. Strauss D. G. Stockbridge N. (2016). The comprehensive in vitro proarrhythmia assay (CiPA) initiative - update on progress. J. Pharmacol. Toxicol. Methods. , doi: 10.1016/j.vascn.2016.06.002.

10.1161/01.RES.77.5.950

Crumb W. J. Jr Vicente J. Johannesen L. Strauss D. G. (2016). An evaluation of 30 clinical drugs against the comprehensive in vitro proarrhythmia assay (CiPA) proposed ion channel panel. J. Pharmacol. Toxicol. Methods.doi: 10.1016/j.vascn.2016.03.009.

10.1016/j.taap.2013.04.027

10.1177/1087057115594589

10.1177/0091270010381498

10.1046/j.1542-474X.2003.08413.x

10.1016/j.vascn.2014.09.005

Gilead Sciences (2013). I. Ranexa (Ranolazine), label information.

10.1093/toxsci/kfr158

10.1093/toxsci/kft205

10.1093/toxsci/kft113

Hernandez, 2016, Electrical stimulation promotes cardiac differentiation of human induced pluripotent stem cells, Stem Cells Int., 2016, 1718041., 10.1155/2016/1718041

Hoekstra, 2012, Induced pluripotent stem cell derived cardiomyocytes as models for cardiac arrhythmias, Front. Physiol, 3, 346., 10.3389/fphys.2012.00346

10.1002/cpt.205

10.1038/clpt.2014.155

10.1016/j.stem.2010.12.008

10.1089/scd.2009.0349

10.1161/CIRCRESAHA.112.300567

Kolb, 2008, Late dofetilide-associated life-threatening proarrhythmia, Int. J. Cardiol, 127, e54, 10.1016/j.ijcard.2007.04.014

Kramer, 2013, MICE models: Superior to the HERG model in predicting Torsade de Pointes, Sci. Rep., 3, 2100., 10.1038/srep02100

10.1124/jpet.104.073692

10.1038/nbt1327

10.1177/1087057114557232

10.1126/scitranslmed.3003623

10.1152/ajpheart.00694.2011

Maddah, 2015, A non-invasive platform for functional characterization of stem-cell-derived cardiomyocytes with applications in cardiotoxicity testing, Stem Cell Rep., 4, 621, 10.1016/j.stemcr.2015.02.007

Nagra, 2005, Marked QT prolongation and torsades de pointes secondary to acute ischemia in an elderly man taking dofetilide for atrial fibrillation: A cautionary tale, J. Cardiovasc. Pharmacol. Ther., 10, 191, 10.1177/107424840501000307

Navarrete, 2013, Screening drug-induced arrhythmia [corrected] using human induced pluripotent stem cell-derived cardiomyocytes and low-impedance microelectrode arrays, Circulation, 128(11 Suppl 1), S3, 10.1161/CIRCULATIONAHA.112.000570

Pfizer (1999). Tikosyn (Dofetilide), label information.

Pharm. Res. Assoc. (1999). Cardioquin (Quinidine Polygalacturonate), label information.

10.1016/S0008-6363(02)00846-5

10.1111/j.1540-8159.2005.00179.x

10.1016/j.ahj.2013.11.004

10.1007/s40264-013-0016-z

10.1016/j.cell.2007.11.019

10.1016/j.cell.2006.07.024

Talajic, 1987, Comparative electrophysiologic effects of intravenous amiodarone and desethylamiodarone in dogs: Evidence for clinically relevant activity of the metabolite, Circulation, 75, 265, 10.1161/01.CIR.75.1.265

10.1128/AAC.06396-11

10.1038/nature06894

10.1161/CIRCULATIONAHA.113.007765