PDF(Pubmed)
Abstract：
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.
摘要：
慢性伤口是一个巨大的全球负担，数百万人患有令人衰弱的并发症。尽管标准护理，由于持续的炎症和受损的组织再生等因素，受损的愈合持续存在。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，在工程纳米级递送系统中递送干细胞衍生的治疗货物。这篇综述探讨了开创性的生物工程策略，以将MSC-EV设计成用于慢性伤口的精密纳米疗法。CRISPR基因编辑等新兴技术，微流体制造，仿生递送系统因其增强MSC-EV靶向的潜力而被强调，优化治疗性货物富集，并确保一致的临床级生产。然而,关键的障碍仍然存在，包括批次可变性，对潜在致瘤性进行严格的安全性评估，免疫原性,和生物分布分析。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翻译的关键。通过克服这些挑战，工程MSC-EV可以催化现成的再生疗法的新时代，为数百万受无法愈合的伤口折磨的人恢复希望和愈合。
