Significance Statement
Human induced pluripotent stem cells (hiPSCs) have been expected to transform drug discovery by providing physiologically relevant cells for toxic compound identification and compound screening. When Shimada M et al. (J Hepatol. 2012;56: 299-300) considered two reports (Moriguchi H et al.; Hepatology. 2010; 51: 344–345 and 351–352) published in 2010 investigating the antiviral efficacy of pitavastatin against hepatitis C virus (HCV) infection in vitro, they conducted a randomized controlled trial (J Hepatol. 2012;56: 299-300). As a result, the results of 2010 proof-of-concept studies of the antiviral efficacies and safety of pitavastatin against HCV infection using a replicon system and human hepatocyte-like cells from hiPSCs (Moriguchi H et al.; Hepatology. 2010; 51: 344–345 and 351–352) were confirmed in a randomized controlled trial published by Shimada M et al. in 2012 (J Hepatol. 2012;56: 299-300). Therefore, this series of studies (Moriguchi H et al.; Hepatology. 2010; 51: 344–345 and 351–352, Shimada M et al.; J Hepatol. 2012; 56: 299-300) would be the first to report clinical applications of hiPSCs. Furthermore, after the clinical trial by Shimada M et al. (J Hepatol. 2012; 56: 299-300), the antiviral efficacies and safeties of pitavastatin against HCV infection were more confirmed in the two clinical studies (Kohjima M et al.; J Med Virol. 2013: 85: 250-260 and Yokoyama S et al.; Aliment Pharmacol Ther. 2014; 39: 443-444). Therefore, to investigate the antiviral efficacies and safety of pitavastatin against HCV infection using a replicon system and human hepatocyte-like cells from hiPSCs (Moriguchi H et al.; Hepatology. 2010; 51: 344–345 and 351–352) would be a rational approach as new drug discovery.
Journal Reference
Clin Res Hepatol Gastroenterol. 2015;39(5):541-3.
Moriguchi H.
Oak Clinic, 2-7-9, Tamade-Nishi, Nishinari-ku, 557-0045 Osaka, Japan. Electronic address: [email protected].
Abstract
Human induced pluripotent stem (iPS) cells may transform drug discovery. Here I show an example of the development of statin (HMG-CoA reductase inhibitors)-based therapy for patients with hepatitis C virus (HCV) infection using human iPS cell technology. When Shimada et al. considered the two reports on the antiviral effects of pitavastatin for HCV infection in vitro by Moriguchi et al., they conducted a randomized controlled trial. As a result, a proof-of-concept for the antiviral effect of pitavastatin against HCV infection using human iPS cell technology by Moriguchi et al. was confirmed in the randomized controlled trial by Shimada et al. in 2012. Therefore, above-mentioned a series of studies became to the first to report the clinical application of human iPS cells. Furthermore, here I propose that new clinical research methods using human iPS cell technology will be able to circumvent the limitations of conventional randomized controlled trials (RCTs) for the purpose of personalized medicine in the clinical setting.
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