Unravelling exosome paradigm: Therapeutic, diagnostic and theranostics application and regulatory consideration

IF 5.1 2区医学 Q1 MEDICINE, RESEARCH & EXPERIMENTAL Life sciences Pub Date : 2025-02-15 DOI:10.1016/j.lfs.2025.123472

Reetika Tandon, Nidhi Srivastava

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Abstract

In the recent decade, extracellular vesicles (EVs) have been released from nearly all the kingdoms, modulating intercellular communication and maintaining the human body's homeostasis by regulating different cellular processes. Among EVs, exosomes are the emerging field in biopharmaceuticals. They have lipid bilayer ranging from 30 to 150 nm in size and encompass DNA, RNA, protein lipids, etc. Their sources are widespread, easy to acquire, and cost-effective in manufacturing. This review focuses on the detailed classification of exosomes existing in nature, knowledge and application of omics, therapeutic, diagnostic and theranostic application of exosomes. It covers diseases such as cancer, infectious diseases (viral, bacterial, fungal infections), neurodegenerative diseases, metabolic diseases, lifestyle diseases (diabetes, cardiovascular, gastric disorder (IBD)), autoimmune disorders and their biodistribution. This article unfolds the recent progress in the exosomes arena and covers all the regulatory considerations (FDA, EMA, and other nations) involved with it. Moreover, a detailed discussion about clinical trials and its manifestation with exosomes and challenges associated with their isolation procedures, reproducibility, and safety concerns.

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解开外泌体范式：治疗，诊断和治疗应用和监管考虑。

近十年来，细胞外囊泡（extracellular vesicles, EVs）几乎从所有领域被释放出来，通过调节不同的细胞过程来调节细胞间的通讯和维持人体的内稳态。在电动汽车中，外泌体是生物制药领域的新兴领域。它们具有30 ~ 150 nm大小的脂质双分子层，包含DNA、RNA、蛋白质脂质等。它们的来源广泛，容易获得，并且在制造中具有成本效益。本文综述了外泌体的分类、组学的知识和应用、外泌体的治疗、诊断和治疗应用。它涵盖了癌症、传染病（病毒、细菌、真菌感染）、神经退行性疾病、代谢疾病、生活方式疾病（糖尿病、心血管疾病、胃疾病（IBD））、自身免疫性疾病及其生物分布等疾病。本文揭示了外泌体领域的最新进展，并涵盖了与之相关的所有监管考虑（FDA， EMA和其他国家）。此外，还详细讨论了外泌体的临床试验及其表现，以及与分离程序、可重复性和安全性相关的挑战。

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来源期刊

Life sciences 医学-药学

CiteScore

12.20

自引率

1.60%

发文量

841

审稿时长

6 months

期刊介绍： Life Sciences is an international journal publishing articles that emphasize the molecular, cellular, and functional basis of therapy. The journal emphasizes the understanding of mechanism that is relevant to all aspects of human disease and translation to patients. All articles are rigorously reviewed. The Journal favors publication of full-length papers where modern scientific technologies are used to explain molecular, cellular and physiological mechanisms. Articles that merely report observations are rarely accepted. Recommendations from the Declaration of Helsinki or NIH guidelines for care and use of laboratory animals must be adhered to. Articles should be written at a level accessible to readers who are non-specialists in the topic of the article themselves, but who are interested in the research. The Journal welcomes reviews on topics of wide interest to investigators in the life sciences. We particularly encourage submission of brief, focused reviews containing high-quality artwork and require the use of mechanistic summary diagrams.