Extracellular vesicle therapeutics for cardiac regeneration: Overcoming standardization hurdles

Abstract

A study by ShamsEldeen et al published in the recent issue of World Journal of Stem Cells, the therapeutic efficacy of mesenchymal stem cell-derived extracellular vesicles (EVs) and moderate exercise was evaluated in a rat model of myocardial infarction. The results revealed that these two interventions exert a synergistic effect to facilitate functional recovery of the injured myocardium. The established therapeutic potential of EVs across multiple diseases, combined with the evidence from this study, underscores the inevitable progression of EV-based therapies toward clinical translation. This article therefore focuses on the core challenges hindering the clinical translation of EV-based therapies: The production and isolation of EVs in sufficient quantities with high purity; the establishment of a multidimensional quality control system; the accurate prediction of therapeutic efficacy; the guarantee of safe and effective clinical application; and the establishment of a proactive defense system against potential risks. These challenges are pressing practical issues that require immediate resolution. Addressing these challenges will require leveraging preclinical evidence to establish a robust, standardized system for EVs - encompassing production, quality control, potency assessment, clinical translation, and risk mitigation - to facilitate their streamlined transition into clinical practice.

Keywords: Mesenchymal stem cells; Extracellular vesicles; Exercise training; Myocardial infarction; Combination therapy; Clinical translation; Cardiac regeneration

Core Tip: This article systematically summarizes the findings and mechanisms elucidated by ShamsEldeen et al, based on current preclinical evidence, outlines the key challenges and countermeasures in translating extracellular vesicle - based therapies into clinical practice - paving the way for future clinical applications that may benefit a broader patient population, including but not limited to those with cardiac diseases. Furthermore, it provides a preliminary outlook on strategies for optimizing therapeutic efficacy, scaling up production, and expanding into diverse disease areas.