A non-animal new approach methodology to test predict human cardiotoxicity like safety concerns

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Catalogue Name :
CardioSight
Cell Type/ Tissue:
TRANS-MSC

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A non-animal new approach methodology to test predict human cardiotoxicity like safety concerns

Cell type used as testing platform
TRANS-MSC: Characterized Configured Human induced Pluripotent Stem Cells (HiPSC) type of adult primary and progenitors
Insilico platform used to publish the report
CardioSight software (trained on Convolutional Neural Network)
Assay endpoints:
Cardiotoxicity
Cardiotoxicity is responsible for about 45% of drugs being withdrawn from the market. Prior to the introduction of human induced pluripotential stem (HiPSC) cell-derived cardiomyocytes, it was virtually impossible to study the effects of in vitro, human drug-induced cardiotoxicity, the results of which could be extrapolated to human clinical trials. All studies had to be performed on animal tissues, which do not provide the best extrapolation models for the human situation. Cardiomyocytes produce high concentrations of intracellular ATP (iATP) due to their high metabolic activity. Changes in iATP concentration directly correlate with cellular and mitochondrial integrity and cytotoxicity that are read outs in CardioSight assay system

Reference:

Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC. An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs). Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. PMID: 32325112.

Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, Turner JR, Sager PT. Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. Ther Innov Regul Sci. 2019 Jul;53(4):519-525. doi: 10.1177/2168479018795117. Epub 2018 Aug 29. PMID: 30157676

Available Resources

Catalogue Name :
CardioSight
Cell Type/ Tissue:
TRANS-MSC

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