Quality Metrics for Stem Cell-Derived Cardiac Myocytes

Advances in stem cell manufacturing methods have made it possible to produce stem cell-derived cardiac myocytes at industrial scales for in vitro muscle physiology research purposes. Although FDA-mandated quality assurance metrics address safety issues in the manufacture of stem cell-based products, no standardized guidelines currently exist for the evaluation of stem cell-derived myocyte functionality. As a result, it is unclear whether the various stem cell-derived myocyte cell lines on the market perform similarly, or whether any of them accurately recapitulate the characteristics of native cardiac myocytes. We propose a multiparametric quality assessment rubric in which genetic, structural, electrophysiological, and contractile measurements are coupled with comparison against values for these measurements that are representative of the ventricular myocyte phenotype. We demonstrated this procedure using commercially available, mass-produced murine embryonic stem cell- and induced pluripotent stem cell-derived myocytes compared with a neonatal mouse ventricular myocyte target phenotype in coupled in vitro assays. •Comprehensive evaluation of stem cell-derived cardiac myocyte form and function•A multifactorial rubric for stem cell-derived myocyte quality assurance•Direct comparison of stem cell-derived myocytes and isolated cardiac myocytes Techniques for differentiating pluripotent stem cells into cardiac myocytes have advanced to the point that such cells are now mass produced for commercial distribution. However, little effort has been made to ensure that these mass-produced myocytes exhibit the functional performance characteristics of the healthy, mature myocardium. Parker and colleagues have a developed a tissue engineering test bed for stem cell-derived myocytes that allows multifactorial evaluation of cardiac myocyte form and function, as well as comparison against a target cardiac phenotype.