FIGURE 6.

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.