[Development of Mesenchymal Stem Cell-derived Extracellular Vesicle Preparations for Practical Application]

Mesenchymal stem cells (MSCs) have emerged as a leading cell source in regenerative medicine due to their multipotency and immunomodulatory capabilities. In recent years, extracellular vesicles (EVs) derived from MSCs have attracted increasing attention as a novel, cell-free therapeutic modality, exhibiting many of the biological effects similar to their parent cells. This review outlines the current status and future prospects of MSC-derived EVs, focusing on their therapeutic mechanisms, standardization efforts, and regulatory trends in Japan and overseas. We further discuss the challenges in the development of EV-based products, including scalable manufacturing, quality control strategies, viral safety, and impurity profiling. The application of Quality by Design (QbD) and single-particle analytics is also highlighted as a means to enhance product consistency and clinical reliability. MSC-EVs have the potential to revolutionize treatment paradigms for various refractory diseases, but their successful implementation will require harmonization of scientific, technical, and regulatory frameworks. This review provides a comprehensive overview of the translational pathway from basic research to clinical and commercial application of MSC-EV therapeutics.