Evidence map›Paper›PMID 40804047›Full record

ReviewSignal transduction and targeted therapy2025

Extracellular vesicle-based drug overview: research landscape, quality control and nonclinical evaluation strategies.

Gangling Xu, Jing Jin, Zhihao Fu, Guangming Wang, Xinhua Lei, Jun Xu, Junzhi Wang

Erratum issuedAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Signal transduction and targeted therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 160 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
160citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

160 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  19. Nanomaterials-Based Immunotherapy for Atherosclerosis.Small (Weinheim an der Bergstrasse, Germany) · 2026
    Review
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100 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Gangling Xu *National Institutes for Food and Drug Control, Beijing, China.
Jing Jin *National-Local Joint Engineering Laboratory of Animal Models for Human Disease, The First Hospital of Jilin University, Jilin, Changchun, China.
Zhihao Fu *National Institutes for Food and Drug Control, Beijing, China.
Guangming WangEast Hospital, Stem Cell Research Center, School of Medicine, Tongji University, Shanghai, China.
Xinhua LeiNational-Local Joint Engineering Laboratory of Animal Models for Human Disease, The First Hospital of Jilin University, Jilin, Changchun, China.ORCID http://orcid.org/0000-0002-3581-6419
Jun XuEast Hospital, Stem Cell Research Center, School of Medicine, Tongji University, Shanghai, China. xunymc2000@yahoo.com.
Junzhi WangNational Institutes for Food and Drug Control, Beijing, China. wangjz@nifdc.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Extracellular vesicles share lipid‒protein membranes with their parent cells, allowing for the targeted transfer of bioactive cargo to recipient cells for functional modulation. The biological features allow extracellular vesicles to serve both as intrinsic therapeutics and as engineered delivery vehicles for targeted molecule transport. In recent years, extracellular vesicle-based therapy has shown great potential as a new therapeutic approach for traumatic conditions and degenerative, acute, and refractory diseases. As extracellular vesicle engineering continues to evolve, more innovative drugs are expected to receive investigational new drug approvals and marketing approvals from regulatory agencies in the future. However, many challenges exist in terms of mechanistic understanding, engineering modifications, manufacturing processes, quality control, and nonclinical research, and no drug regulatory authorities have currently issued specific technical evaluation guidelines for extracellular vesicle-based drugs, all of which have hindered the clinical translation of these drugs. In this article, which is focused primarily on extracellular vesicles derived from mammalian cells, we summarize the clinical translation and process development research status of extracellular vesicle-based drugs and propose both general considerations and key aspects of quality control strategies and nonclinical evaluations in the development process. The aim of this review is to provide valuable references for the development and evaluation of extracellular vesicle-based products, accelerate the clinical translation process, and benefit patients as soon as possible.

Indexed as

Drug Delivery SystemsExtracellular VesiclesAnimalsHumansQuality Control

Identifiers

PMID40804047
PMCPMC12350758

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.