Exosomal biomarkers in leukemia: translational potential and regulatory challenges for precision medicine applications

作者：Mohammad Amin Ansarian, Mahsa Fatahichegeni, Yuqi Wang, Juan Ren, Tongxin Zhang, Xiaoning Wang · 发表于：Frontiers in Immunology · 年份：2025 · DOI：10.3389/fimmu.2025.1677088 · 被引用次数：12 · 研究领域：Extracellular vesicles in disease、MicroRNA in disease regulation、Circular RNAs in diseases

Exosomes represent a paradigm shift in leukemia biomarker research, evolving from overlooked cellular waste products to sophisticated intercellular messengers with significant clinical implications for hematological malignancies. These membrane-bound vesicles carry disease-specific molecular cargo, including proteins, lipids, and nucleic acids that mirror leukemic cell pathology, making them accessible through minimally invasive liquid biopsies. Current evidence demonstrates characteristic molecular signatures across different leukemia subtypes, with exosomal microRNAs such as miR-150, miR-155, and the miR-29 family showing diagnostic and prognostic value, while protein markers including CD19, CD20, and IFITM3 correlate with disease status and therapeutic responses. Beyond diagnostic applications, exosomes orchestrate complex biological processes that reshape the bone marrow microenvironment, facilitate immune evasion, and promote treatment resistance through intercellular molecular exchange, presenting both challenges and therapeutic opportunities. Clinical translation has gained momentum through European regulatory frameworks, with exosomes classified as advanced therapy medicinal products under EMA guidelines. Early clinical trials demonstrate safety and feasibility, while diagnostic precedents like the ExoDx Prostate Test provide regulatory pathways for implementation. However, significant obstacles persist, including standardization of isolation methods, validation of bi...