International Journal of Molecular and Cellular Medicine (IJMCM)
Cellular and Molecular Biology Research Center, Babol University of Medical Sciences
چهارشنبه 23 مهر 1404
[Archive]
دوره 14، شماره 3 - ( 6-1404 )
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Yeganeh F, Parsian H. Counting Copies, Making Medicines: A Roadmap for the MSC-EV-microRNAome. Int J Mol Cell Med 2025; 14 (3) :793-796
URL: http://ijmcmed.org/article-1-2681-fa.html
URL: http://ijmcmed.org/article-1-2681-fa.html
Counting Copies, Making Medicines: A Roadmap for the MSC-EV-microRNAome. مجله بین المللی سلولی و مولکولی. 1404; 14 (3) :793-796
: (35 مشاهده)
Mesenchymal stromal cell–derived extracellular vesicles (MSC-EVs) are promising candidates for cell-free therapeutics, but the copy-number mathematics -most EVs contain fewer than one copy of a given microRNA (miRNA)- forces a reconsideration of mechanisms and development strategies. Translation will require disciplined adherence to MISEV2023 standards: definitions of transparent source and separation; absolute quantification of cargo by digital PCR (dPCR) or UMI-aware small RNA sequencing; and validated potency assays (e.g., NF-κB suppression, macrophage polarization) linked to critical quality attributes (CQAs). Dosing should evolve from particle/protein counts to a triad of particles, protein, and miRNA copies, ideally tied to activity-based units. Clean separations are essential to avoid misattributing effects to vesicles in the presence of non-vesicular RNA. Safety assessment, including TF/CD142 and thrombogenicity, must guide route selection. Manufacturing should standardize CPP-to-CQA control in TFF-based systems, while stability testing must minimize freeze–thaw cycles and validate lyophilization. The first approvable product will likely use local delivery, a small number of defined miRNAs, and copy-number-anchored dosing. The translational mandate is clear: count molecules, link counts to function, and dose based on biology.
نوع مطالعه: Editorial |
موضوع مقاله:
Cell Biology
دریافت: 1404/6/15 | پذیرش: 1404/6/23 | انتشار: 1404/7/9
دریافت: 1404/6/15 | پذیرش: 1404/6/23 | انتشار: 1404/7/9
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