Key Steps in Murine Cardiac Engineering Validation: How Does It Affect the Efficiency of Cardiac Devices?

Acute myocardial infarction is one of the leading causes of death in the world. Owing to the limited regenerative capacity of the heart, the development of therapeutic devices using cell therapy and tissue engineering has gained importance. Preclinical validation of these devices can provide evidence of their safety and efficacy in implantation in infarcted myocardium. In view of the growing number of proposed devices, it is necessary to establish an appropriate experimental protocol that mimics the clinical scenario. This review is aimed at describing the strategies used for the preclinical validation of an artificial myocardium, based on the purpose of the therapy and the experimental design. Overall, the development of cardiac devices has focused on in vitro or in situ strategies for cell delivery to the infarcted tissue and proper cell proliferation and differentiation. Efforts have also been made to search for new cell sources, blood vessel formation, development of an anti-inflammatory phenotype, and electromechanical coupling of resident and implanted cardiomyocytes. Based on the published evidence, a seven-stage process for the preclinical validation of cardiac regenerative therapy is proposed.