Abstract:

Exosomes， natural extracellular vesicles measuring 30~150 nm in diameter， serve as critical carriers for intercellular communication. The bioactive molecules they carry， including proteins， nucleic acids and lipids， have made them a research hotspot in biomedicine. With the development of biotechnology， exosomes have shown great potential in the fields of disease diagnosis， drug delivery and tissue regeneration. This review systematically elaborated on the basic biological characteristics of exosomes， the latest breakthroughs in their engineering modification technologies （including genetic engineering， microfluidic technology and chemical modification）， and their innovative applications in cancer therapy， tissue repair and neurodegenerative diseases. Furthermore， we conducted an in-depth analysis of the key challenges in clinical translation： large-scale production， targeting optimization and standardization. Finally， we looked forward to future directions such as artificial intelligence （AI）-assisted design， personalized medicine， and other future directions. Thanks to their unique biocompatibility and programmability， engineered exosomes are expected to serve as a "next-generation drug delivery platform"， providing a new paradigm for precision medicine and holding broad clinical application prospects.

Key words: exosomes, engineering strategies, clinical translation

摘要：

外泌体（exosomes）是直径30~150 nm的天然细胞外囊泡，作为细胞间通讯的关键载体，其携带的蛋白质、核酸、脂质等生物活性分子，使其成为生物医学的研究热点。随着生物技术的发展，外泌体在疾病诊断、药物递送和组织再生等领域展现出巨大潜力。系统阐述了外泌体的基础生物学特性、工程化改造技术（包括基因工程、微流控和化学修饰）的最新突破，及其在肿瘤治疗、组织修复和神经退行性疾病中的创新应用。同时，深入分析了临床转化面临的关键挑战：规模化生产、靶向性优化与标准化。最后，展望了人工智能辅助设计、个性化医疗等未来研发方向。凭借独特的生物相容性与可编程性，工程化外泌体有望作为“下一代药物递送平台”，为精准医疗提供全新范式，具有广阔的临床应用前景。

关键词: 外泌体, 工程化改造, 临床转化