• Stem cell-derived EVs demonstrate significant therapeutic potential in preclinical and clinical settings, particularly for tissue repair and immune modulation.
• Standardization of EV isolation, characterization, and production is critical for clinical translation and regulatory approval.
• Engineering strategies, such as surface modification and cargo loading, enhance EV targeting and therapeutic efficacy.
• EVs offer a safer alternative to whole-cell therapies, reducing risks of immunogenicity and tumorigenicity.