Therapeutic Potential of Extracellular Vesicles: From Biogenesis, Isolation and Molecular Characterization - From Translational Gaps to Regulatory Barriers - A Review

Sep 23, 2026

Uploaded by Theodore

Therapeutic potential of extracellular vesicles is reviewed, tracing workflows from vesicle biogenesis through isolation and molecular characterization. The review links mechanistic findings to translational challenges, emphasizing gaps that limit clinical translation. It also addresses regulatory barriers that shape development pathways, aiming to clarify how experimental outputs can be made more consistent, reproducible, and decision-ready for therapeutic use. The scope covers multidisciplinary evidence relevant to bench-to-bedside progress.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages42

Reading Time1 h 46 min

AccessFree to download

Therapeutic Potential of Extracellular Vesicles

From Biogenesis to Isolation

Molecular Characterization

Addressing Translational Gaps

Regulatory Barriers

Review Therapeutic Potential of Extracellular Vesicles: From Biogenesis, Isolation and Molecular Characterization to Addressing Translational Gaps and Regulatory Barriers Dragan Primorac 1,2,3,4,5,6,7,8,9,10,11, Petar Brlek 1,2,3,12, *, Luka Buli´c 1,2,3, Nenad Hrvatin 1,13, Vedrana Škaro 2, Petar Proji´c 2, Martina Glavan 14, Ijeoma Oleru 14, Pierre Rocheteau 15, Carlo Tremolada 15,16, Ariana DeMers 17, Mary A. Ambach 18, Don Buford 19, Tamara Kneževi´c 1, Dimitrios Kouroupis 20,21, Cole Conforti 20,21, D. Wood Kimbrough 20,21, R. Peter Schnorr 22, Lindsay Williams 23, Raminta Vaiciuleviciute 24, Žan Fortuna 25, Lara Oprešnik 25, Blaž Curk 25, Miomir Kneževi´c 25, Gordana Kalan Živˇcec 25, Adelina Hrka´c 1, Dimitrios Tsoukas 26, Ilona Uzieliene 27, Jolita Pachaleva 27, Eiva Bernotiene 27, Kristiana Barbato 21,28, Neep Patel 20,21, Isabella Demirdjian Guanche 28, Evangelos V. Badiavas 28, Jana Meši´c 1,3, Ana Medi´c Flajšman 1, Romina Milaniˇc 1, Danijela Klari´c 1, Vasiliki E. Kalodimou 29, Massimo Allegri 30, Johannes Brachmann 8, Wei Seong Toh 31,32, Nancy Duarte Delgado 33 and Ali Mobasheri 27,33,34,35 Academic Editor: Simone Anfossi Received: 22 December 2025 Revised: 16 January 2026 Accepted: 21 January 2026 Published: 9 February 2026 Copyright: © 2026 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. 1 St. Catherine Specialty Hospital, 10000 Zagreb, Croatia; [dragan.primorac@svkatarina.hr](dragan.primorac@svkatarina.hr) (D.P.); [luka.bulic@svkatarina.hr](luka.bulic@svkatarina.hr) (L.B.); nenad.hrvatin@svkatarina.hr (N.H.); [tamara.knezevic@svkatarina.hr](tamara.knezevic@svkatarina.hr) (T.K.); [adelina.surjan@gmail.com](adelina.surjan@gmail.com) (A.H.); [jana.mesic@svkatarina.hr](jana.mesic@svkatarina.hr) (J.M.); [ana.medicflajsman@svkatarina.hr](ana.medicflajsman@svkatarina.hr) (A.M.F.); [romina.milanic@svkatarina.hr](romina.milanic@svkatarina.hr) (R.M.); [danijela.klaric@svkatarina.hr](danijela.klaric@svkatarina.hr) (D.K.) 2 International Center for Applied Biological Research, 10000 Zagreb, Croatia; [vedrana.skaro@icabs.eu](vedrana.skaro@icabs.eu) (V.Š .); [petar.projic@icabs.eu](petar.projic@icabs.eu) (P.P.) 3 School of Medicine, Josip Juraj Strossmayer University of Osijek, 31000 Osijek, Croatia 4 Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, 31000 Osijek, Croatia 5 Eberly College of Science, The Pennsylvania State University, State College, PA 16802, USA 6 School of Medicine, University of Split, 21000 Split, Croatia 7 The Henry C. Lee College of Criminal Justice and Forensic Sciences, University of New Haven, New Haven, CT 06516, USA 8 Sana Kliniken Oberfranken, 96450 Coburg, Germany; [johannes.brachmann@regiomed-kliniken.de](johannes.brachmann@regiomed-kliniken.de) 9 School of Medicine, University of Rijeka, 51000 Rijeka, Croatia 10 School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA 11 National Forensic Sciences University, Gandhinagar 382007, India 12 Department of Molecular Biology, Faculty of Science, University of Zagreb, 10000 Zagreb, Croatia 13 Department of Pediatrics, Clinical Hospital Center Rijeka, 51000 Rijeka, Croatia 14 Department of Neuroscience, Yale School of Medicine, Yale University, 333 Cedar Street, New Haven, CT 06510, USA; [martina.glavan@yale.edu](martina.glavan@yale.edu) (M.G.); [ijoleru@gmail.com](ijoleru@gmail.com) (I.O.) 15 Exogems SA, Biopole, 1066 Epalinges, Switzerland; [pierre.rocheteau@gmail.com](pierre.rocheteau@gmail.com) (P.R.); [carlo.tremolada@gmail.com](carlo.tremolada@gmail.com) (C.T.) 16 Image Regenerative Clinic, 20122 Milano, Italy 17 Restore Orthopedics and Sports Medicine, Sonora, CA 95370, USA; [arianademers@gmail.com](arianademers@gmail.com) 18 BioEvolve, San Diego Orthobiologics and Sports Center, San Diego, CA 92024, U

FAQs

What does the review cover about extracellular vesicles?

It reviews extracellular vesicles from biogenesis to isolation and molecular characterization, then connects these topics to translational challenges and regulatory constraints.

How does the review link basic research to clinical translation?

It focuses on translational gaps that hinder progress, highlighting where evidence needs improvement for therapeutic development.

Why are regulatory barriers important in the review’s discussion?

Regulatory barriers are discussed as part of the obstacles that influence how vesicle-based therapies can be developed and evaluated for clinical use.

Sep 23, 2026

Uploaded by Theodore