International Journal of Molecular and Cellular Medicine (IJMCM)
Babol University of Medical Sciences
Wed, Oct 15, 2025
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Volume 14, Issue 3 (Int J Mol Cell Med 2025)
Int J Mol Cell Med 2025, 14(3): 793-796 |
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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-en.html
URL: http://ijmcmed.org/article-1-2681-en.html
1- Department of Immunology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
2- Cellular and Molecular Biology Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. ,hadiparsian@yahoo.com
2- Cellular and Molecular Biology Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. ,
Abstract: (36 Views)
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.
Keywords: Mesenchymal stromal cells (MSCs), Extracellular vesicles (EVs), microRNA (miRNA), MSC-EV-microRNAome, MISEV2023
Type of Study: Editorial |
Subject:
Cell Biology
Received: 2025/09/6 | Accepted: 2025/09/14 | Published: 2025/10/1
Received: 2025/09/6 | Accepted: 2025/09/14 | Published: 2025/10/1
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