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. 2026 Oct 16;14:1976532. doi: 10.3389/fbioe.2026.1976532

FIGURE 6.

Infographic outlining challenges and prospects for hydrogel-extracellular vesicle (EV) systems in wound healing, categorized into four sections: yield and standardized production, hydrogel-EVs system construction, large-scale preparation and sterilization, and regulation and clinical translation, each illustrated with relevant icons and key issues such as variability, lack of standards, batch differences, production limits, regulatory complexity, and safety concerns.

Current challenges and future perspectives for hydrogel-EV systems in wound healing. Key barriers to clinical translation include limited EV yield and batch-to-batch consistency, incomplete standardization of EV isolation and quality control, challenges in EV-hydrogel formulation and activity preservation, scale-up and sterilization requirements, and unresolved regulatory and clinical issues. Translation toward clinical application requires standardized manufacturing, validated quality-control and release criteria, systematic safety assessment, and evaluation of pharmacokinetics and biodistribution. EVs, extracellular vesicles; CMC, chemistry, manufacturing, and controls; QC, quality control; PK, pharmacokinetics; FDA, U.S. Food and Drug Administration; EMA, European Medicines Agency.