Quality Evaluation Considerations for Stem Cell‐Derived Extracellular Vesicles‐Based Therapeutic Products in China

Stem cell therapy is currently undergoing clinical research in China for conditions that are resistant to or incurable by traditional pharmaceutical interventions. Stem cell-derived extracellular vesicles (EVs) exhibit therapeutic effects similar to those of their parent stem cells, positioning them as an alternative or adjunctive approach to stem cell therapy. In recent years, given the tremendous potential for EVs in disease treatment, many researchers have focused on the development of stem cell-derived EVs and have achieved substantial progress in large-scale production and quality-related studies. However, at present, there are no specific or targeted regulatory requirements issued by authorities in China regarding the regulation of this novel therapeutic modality or the assurance of its safety and efficacy. In this paper, based on the biological properties of EVs, recent research advances, current understanding of their mechanisms of action, manufacturing processes and quality control strategies, a comprehensive framework for the quality evaluation of stem cell-derived EV-based therapeutic products is proposed. This framework is intended to serve as a reference for researchers and developers and may help to facilitate further discussion to facilitate further discussion, thereby supporting and promoting the development, regulatory oversight and establishment of quality standards and evaluation systems for stem cell-derived EVs in China.