The mission of our electrophysiology group in this study is to test the (pro-)arrhythmic potential of 28 compounds (blinded to the participants) on hiPSC-derived cardiomyocytes from both Cellular Dynamics and NCardia using the 96-well version of the Multiwell MEA system by Multi Channel Systems. Together with the data obtained by the other core sites this data will be used to assess the usability of hiPSC-derived cardiomyocytes on the MEA system.
As member of HESI, the NMI already participated successfully in the CiPA Myocyte pilot study in 2014/2015.
CiPA (the Comprehensive in Vitro Proarrhythmia Assay initiative) is a project driven by the Health and Environmental Science Institute (HESI), the FDA and the Safety Pharmacology Society. It aims to optimize the assessment of clinical potential of TdP and to replace the preclinical hERG current assay required under the ICH S7B safety pharmacology guideline.
For more information visit www.cipaproject.org
CiPA cardiomyocyte services
Drug-induced wanted and adverse effects on cardiac function can be observed in our test system, as a prolongation of the fAP duration (“QT-interval in vitro”) and/or arrhythmic beating behaviour of the electrically coupled cardiomyocytes.