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Related Experiment Video

Updated: Jul 2, 2026

Characterizing Extracellular Vesicles from Biological Fluids
05:07

Characterizing Extracellular Vesicles from Biological Fluids

Published on: February 28, 2025

Extracellular Vesicles for Therapeutic Applications: A Translational Framework Integrating Sources, Administration

Fen Zhang1, Lan Xing1, Wanglong Chu1

  • 1Cell Preparation Center, Shenzhen Beike Biotechnology Co., Ltd., Shenzhen, Guangdong, People's Republic of China.

International Journal of Nanomedicine
|July 1, 2026
PubMed
Summary

Extracellular vesicles (EVs) offer promising therapeutic potential but face clinical hurdles. This review outlines EV sources, delivery routes, and applications, proposing a framework to overcome translational bottlenecks for precision EV therapy.

Keywords:
administration routeclinical translationextracellular vesiclesprecision therapyregulatory specificationsource heterogeneity

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Area of Science:

  • Biotechnology and Nanomedicine
  • Cellular and Molecular Biology
  • Drug Delivery Systems

Background:

  • Extracellular vesicles (EVs) are key mediators of intercellular communication, transporting bioactive molecules.
  • EVs show promise as acellular therapeutic platforms due to their biocompatibility and targeting capabilities.
  • Clinical translation of EVs is limited by heterogeneity, undefined delivery-disease relationships, and regulatory gaps.

Purpose of the Study:

  • To systematically review EV biological features from diverse sources (e.g., stem cells, microbes, plants).
  • To compare various administration routes (e.g., intravenous, oral, nasal) for EV delivery.
  • To analyze EV therapeutic progress, regulatory policies, and clinical pipelines to identify and address translational challenges.

Main Methods:

  • Comprehensive literature review of EV sources, biological characteristics, and therapeutic applications.
  • Comparative analysis of different EV administration routes and their suitability for specific diseases.
  • Systematic evaluation of global regulatory landscapes and the EV clinical trial pipeline.
  • Development of a five-dimensional matching framework (EV source, route, indication, CQAs, regulations).

Main Results:

  • Detailed comparison of EVs from mesenchymal stem cells, immune cells, tumor cells, plants, milk, microbes, and platelets.
  • Evaluation of intravenous, oral, nasal, inhaled, and local injection delivery modalities for EVs.
  • Summary of EV therapeutic advancements in regenerative medicine, immunotherapy, oncology, and neurological/metabolic disorders.
  • Analysis of regulatory policies and the global EV clinical pipeline up to April 2026.

Conclusions:

  • A five-dimensional framework integrating EV sources, administration routes, disease indications, critical quality attributes (CQAs), and regulatory requirements is proposed.
  • This framework aims to address current translational bottlenecks and commercialization obstacles for EV-based therapeutics.
  • The review provides theoretical support for optimizing EV therapy, establishing unified quality criteria, and accelerating clinical and industrial transformation.