We are very excited that HESI changed our status from non-core to core site for the actual running CiPA myocyte study.
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 Axiogenesis and Cellular Dynamics 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
Additionally we participate in testing 12 blinded compounds on hiPSC-cardiomyocytes from Takara/Cellartis and Pluriomics, who generously sponsor CiPA and us with their cells.
As member of HESI the NMI already successfully participated 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