Defining Biomarkers in Stem Cell-Derived Tissue Constructs for Drug and Disease Screening.

The development of stem cell-derived tissue constructs (SCTCs) for clinical applications, including regenerative medicine, drug and disease screening offers significant hope for detecting and treating intractable disorders. SCTCs display a variety of biomarkers that can be used to understand biological mechanisms, assess drug interactions, and predict disease. Although SCTCs can be derived from patients and share the same genetic make-up, they are nevertheless distinct from human patients in many significant ways, which can undermine the clinical significance of measurements in SCTCs. This study defines biomarkers, how they apply to SCTCs, and clarifies specific ethical issues associated with the use of SCTCs for drug and disease screening.