慢性伤口是全球的一个重大负担，数百万人遭受着使人衰弱的并发症。尽管进行了标准护理，但由于持续炎症和组织再生受损等因素，愈合受损仍然存在。间充质干细胞 (MSC) 衍生的细胞外囊泡 (EV) 提供了一种创新的再生医学方法，在工程纳米级输送系统中输送干细胞衍生的治疗药物。这篇综述探讨了将 MSC-EV 改造为慢性伤口精密纳米疗法的开创性生物工程策略。 CRISPR 基因编辑、微流体制造和仿生递送系统等新兴技术因其增强 MSC-EV 靶向、优化治疗货物富集和确保一致的临床级生产的潜力而受到关注。然而，关键障碍仍然存在，包括批次变异性、对潜在致瘤性、免疫原性和生物分布分析的严格安全性评估。至关重要的是，协调监管科学与生物工程和患者倡导的协作框架是加快全球临床转化的关键。通过克服这些挑战，工程化的 MSC-EV 可以催生现成的再生疗法的新时代，为数百万遭受不愈伤口之苦的人恢复希望和康复。© 2024 作者。

Chronic wounds represent a significant global burden, afflicting millions with debilitating complications. Despite standard care, impaired healing persists due to factors like persistent inflammation and impaired tissue regeneration. Mesenchymal stem cell (MSC)-derived extracellular vesicles (EVs) offer an innovative regenerative medicine approach, delivering stem cell-derived therapeutic cargo in engineered nanoscale delivery systems. This review examines pioneering bioengineering strategies to engineer MSC-EVs into precision nanotherapeutics for chronic wounds. Emerging technologies like CRISPR gene editing, microfluidic manufacturing, and biomimetic delivery systems are highlighted for their potential to enhance MSC-EV targeting, optimize therapeutic cargo enrichment, and ensure consistent clinical-grade production. However, key hurdles remain, including batch variability, rigorous safety assessment for potential tumorigenicity, immunogenicity, and biodistribution profiling. Crucially, collaborative frameworks harmonizing regulatory science with bioengineering and patient advocacy hold the key to expediting global clinical translation. By overcoming these challenges, engineered MSC-EVs could catalyze a new era of off-the-shelf regenerative therapies, restoring hope and healing for millions afflicted by non-healing wounds.© 2024 The Author(s).