Aug 2026· International Journal of Molecular Sciences· Vol 27· 0 citations· 83 references
Medicine
TL;DR
This narrative review integrates current knowledge of exosome biology, diagnostic and therapeutic applications, and engineering strategies and outlines future priorities for advancing exosome-based technologies toward precision medicine.
Abstract
Exosomes are small membrane-bound extracellular vesicles of endosomal origin that play pivotal roles in intercellular communication by transferring proteins, lipids, metabolites, and nucleic acids. Increasing evidence indicates that these vesicles participate in diverse physiological and pathological processes, including immune regulation, tissue repair, tumor progression, neurodegeneration, and cardiovascular homeostasis. Their distinctive biological properties have consequently generated considerable interest in their development as diagnostic tools, therapeutic agents, and drug-delivery platforms. Recent progress in exosome biology and biogenesis, together with technological advances in vesicle isolation, characterization, engineering, and large-scale production, has accelerated their preclinical development and early clinical translation. Nevertheless, substantial challenges—including donor-cell heterogeneity, low production yields, insufficiently standardized protocols, and regulatory uncertainty—must be addressed before widespread clinical implementation can be achieved. This narrative review integrates current knowledge of exosome biology, diagnostic and therapeutic applications, and engineering strategies. It further examines major translational barriers and outlines future priorities for advancing exosome-based technologies toward precision medicine.
Extracellular vesicles (EVs) are nanoscale membrane-bound structures that play a pivotal role in intercellular communication by transporting bioactive molecules, including proteins, lipids, nucleic acids, and organelles, between cells. Originating from the endosomal pathway, EVs reflect the physiological and pathological status of their parent cells and participate in a broad range of biological processes, such as immune regulation, tissue regeneration, and disease progression. This review provides a comprehensive overview of EVs' biology, covering their biogenesis, biochemical composition, isolation strategies, and characterization methodologies. Recent advances in quantitative, qualitative, and single-vesicle analytical techniques are discussed, highlighting both their advantages and technical limitations. Emphasis is placed on the functional roles of EVs in cancer, cardiovascular diseases, autoimmune disorders, intestinal fibrosis, and neural repair, with a focus on their contributions to disease pathogenesis, biomarker discovery, and therapeutic resistance. Furthermore, emerging strategies employing both natural and engineered EVs as therapeutic delivery platforms are examined. Special attention is given to EVs-integrated hydrogel systems designed to improve bioavailability, enhance retention at target sites, and enable controlled therapeutic release. Despite their considerable therapeutic potential, several challenges remain, including the need for standardized isolation protocols, scalable production, management of vesicle heterogeneity, and successful clinical translation. Overall, this review highlights the multifaceted biological significance of EVs and underscores their increasing potential as diagnostic biomarkers and next-generation therapeutic platforms across a wide range of disease conditions.
E. İ. Torunoğlu, Zeynep Betul Sarı, Muhammed Emin Sarı et al.· Biotechnology and Bioenginee...· 0 citations
INTRODUCTION
Exosomes, extracellular vesicles of 30-150 nm generated via fusion of multivesicular bodies with the plasma membrane, have evolved from poorly characterized cellular byproducts into a promising platform for translational medicine. Their intrinsic biological properties, including low immunogenicity, biocompatibility, capacity to cross the blood-brain barrier, and natural tissue tropism, confer fundamental advantages over synthetic nanocarriers.
METHODS
This review systematically covers biogenesis (ESCRT-dependent and ceramide-mediated pathways), molecular cargo composition, cellular sources and GMP-- compliant manufacturing, pharmacokinetics and biodistribution, clinical experience across major disease areas, engineering strategies for cargo loading and surface modification, and the current regulatory landscape.
RESULTS
Exosome biogenesis is orchestrated by ESCRT-0-III complexes and the neutral sphingomyelinase pathway, yielding vesicles enriched in tetraspanins (CD63, CD9, CD81), heat-shock proteins, and functional nucleic acids including miRNA and circRNA. Mesenchymal stromal cell-derived exosomes dominate clinical pipelines, with scalable 3D hollow-fiber bioreactor production enabling GMP-grade manufacturing. Circulating half-lives vary markedly by source: most cell line-derived exosomes are cleared within 2-30 minutes, whereas platelet-derived EVs persist in circulation for 5.3-5.8 hours. These values are substantially prolonged by CD47-mediated phagocytosis evasion and PEGylation. Engineering approaches, LAMP-2B-mediated genetic display of targeting ligands, click chemistry conjugation, and hybrid Exosome-Liposome Nanoparticles (HELN)markedly enhance tissue selectivity and therapeutic potency. Completed Phase I-IIb trials in oncology and pulmonology demonstrate favourable safety profiles without severe systemic adverse events. As of 2025-2026, no extracellular vesicle therapeutic has received regulatory approval by the FDA, EMA, or equivalent agencies.
DISCUSSION
Engineered exosomes combine multicomponent cargo, context-dependent uptake, and tissue tropism in a single platform. Validated potency assays, batch consistency, and regulatory harmonisation remain the principal unresolved barriers to clinical approval.
CONCLUSION
Convergence of AI-driven manufacturing optimisation, multimodal engineering platforms, and international regulatory harmonisation defines the translational roadmap for exosome-based medicines over the coming decade.
M. Shkurnikov, Alexander Tonevitsky· Current Medicinal Chemistry· 0 citations
Exosomes are small extracellular vesicles (30–150 nm) secreted by most cell types, carrying proteins, lipids, and nucleic acids that mediate intercellular communication. Their natural biocompatibility, low immunogenicity, ability to cross biological barriers, and intrinsic targeting properties have attracted intense interest for therapeutic and drug delivery applications. Exosomes can be loaded with small molecules, proteins, or nucleic acids and engineered to display targeting ligands, enabling precise delivery to specific tissues or cells. This review critically examines the current state of exosome-based therapeutics, focusing on isolation methods, engineering strategies, and clinical translation through early 2024. Isolation techniques include ultracentrifugation, size-exclusion chromatography, and microfluidic approaches, each with trade-offs in purity, yield, and scalability. Engineering strategies encompass cargo loading via electroporation, sonication, or co-incubation, and surface modification using chemical conjugation or genetic fusion. Preclinical studies have demonstrated therapeutic potential in oncology, cardiovascular disease, neurological disorders, and regenerative medicine. Several clinical trials are evaluating exosomes, including mesenchymal stem cell-derived exosomes for COVID-19 and graft-versus-host disease, and plant-derived exosomes for drug delivery. Challenges include heterogeneity, scalable manufacturing, batch-to-batch reproducibility, regulatory classification, and biodistribution. Future directions include standardized isolation and characterization, improved cargo loading efficiency, and development of allogeneic off-the-shelf products. Exosome-based therapeutics hold promise, but rigorous quality control and clinical evidence are required.
Unknown authors· Global Journal of Research i...· 0 citations
Extracellular vesicles (EVs) are naturally occurring nanoscale carriers that have gained attention as next-generation platforms for diagnostics, site-specific drug delivery, and tissue engineering owing to their high biocompatibility, minimal immunogenicity, and capacity to transport diverse bioactive cargo across biological barriers. This review discusses the classification, biogenesis, molecular constituents, and therapeutic properties of the major EV subtypes such as exosomes, microvesicles, and apoptotic bodies. It also highlights recent advances in EV engineering for cancer treatment, emphasizing immune modulation and targeted therapeutic delivery. Particular attention is given to plant-derived EVs, which have shown promise as scalable, low-toxicity nanotherapeutics with inherent bioactivity and effective drug delivery potential. Selected preclinical studies, recent patents, and ongoing clinical trials are also summarized, providing an up-to-date perspective on the clinical translation of EV-based technologies. Current challenges in EV isolation, characterization, scalable manufacturing, cargo loading, standardization, and regulatory approval, along with future directions for clinical translation, are summarized. Collectively, this review summarizes the growing applicability of EVs as next-generation platforms for precision medicine, targeted drug delivery, and regenerative therapies while identifying the major obstacles that must be addressed to facilitate their successful clinical translation.
Shery Jacob, Namitha Raichel Varkey, S. Boddu et al.· Pharmaceutics· 0 citations
Exosomes have emerged as key mediators of intercellular and inter-organ communication. Although substantial advances have expanded the understanding of the biology of extracellular vesicles, exosome biogenesis and their role in the disease progression of systemic diseases have not yet been fully elucidated. In this review, we present a comprehensive overview of the molecular pathways responsible for exosome biogenesis, emphasizing how the selective incorporation of proteins, lipids, metabolites, messenger RNAs, and microRNAs (miRs) determines the composition and biological activity of exosomes. We also discuss how exosome-mediated inter-organ communication functions as an integrated biological network that connects the kidney, the cardiovascular system, the brain, the liver, the immune system, and tumors, thereby coordinating the pathological responses underlying the progression of chronic diseases. Additionally, we demonstrate the recent advances in the potential of exosomes as minimally invasive biomarkers and clinical translational implantation. Finally, we discussed the methodological and biological challenges that limit the clinical application of exosomes. Overall, this review presents an integrated framework for understanding exosome biology and supports the concept that exosomes function as dynamic platforms for systemic signaling that link molecular mechanisms to disease pathogenesis and translational medicine.
Adam Madore, Nigel Walsh, K. Desai et al.· Current Issues in Molecular...· 0 citations
Exosomes are nanoscale, membrane-bound vesicles secreted by various cell types. Owing to their cargo of parental cel-derived cellular components, exosomes show significant promise as clinical biomarkers. Meanwhile, due to their diverse origins and cargo, exosomes play a dual role in cancer, possessing the capacity to both promote and suppress tumor progression The efficient and rapid isolation and purification of exosomes are foundational for advancing their clinical applications. Additionally, a comprehensive understanding of exosome biogenesis is essential to elucidate their underlying biological functions. However, current knowledge regarding their biological characteristics and functions of action remains limited. This review delves into exosome isolation techniques, the regulatory mechanisms underlying their biogenesis and secretion, and their dual roles in cancer progression, metastasis, and tumor immunity, concluding with a discussion of the challenges and future directions in their clinical translation.
Ying-Ying Li, Ya Gao, Yanhong Wang et al.· Frontiers in Cell and Develo...· 0 citations
We use cookies to run the site and, with your consent, for analytics and to show ads.
See our Cookie Policy.
