Evidence map›Paper›PMID 41102301›Full record

ArticleScientific reports2025

Safety evaluation of extracellular vesicles derived from hypoxia primed mesenchymal stem cells of umbilical cord and adipose tissue.

Quyen Thi Nguyen, Nhung Thi Hong Dinh, Ngo Thu Hang, Can Van Mao, Xuan-Hai Do, Duc Son Le, Hong-Nhung Dao, T Ngan Giang, Nicholas Forsyth, Van T Hoang and 1 more

Erratum issuedAbstract read
In one paragraph

Article in Scientific reports, 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. Review
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  5. Integrative Approaches to Treating Cellular Senescence in Kidney Disease.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Quyen Thi Nguyen *Vinmec Research Institute of Stem Cell and Gene Technology, College of Health Sciences, Vin University, Vinhomes Ocean Park, Gia Lam District, Hanoi, 12400, Vietnam.
Nhung Thi Hong Dinh *Vinmec Research Institute of Stem Cell and Gene Technology, College of Health Sciences, Vin University, Vinhomes Ocean Park, Gia Lam District, Hanoi, 12400, Vietnam.
Ngo Thu HangDepartment of Pathophysiology, Vietnam Military Medical University, 160 Phung Hung, Ha Dong, Hanoi, Vietnam.
Can Van MaoDepartment of Pathophysiology, Vietnam Military Medical University, 160 Phung Hung, Ha Dong, Hanoi, Vietnam.
Xuan-Hai DoDepartment of Practical and Experimental Surgery, Vietnam Military Medical University, 160 Phung Hung, Ha Dong, Hanoi, Vietnam.
Duc Son LeVinmec Research Institute of Stem Cell and Gene Technology, College of Health Sciences, Vin University, Vinhomes Ocean Park, Gia Lam District, Hanoi, 12400, Vietnam.
Hong-Nhung DaoVinmec Research Institute of Stem Cell and Gene Technology, College of Health Sciences, Vin University, Vinhomes Ocean Park, Gia Lam District, Hanoi, 12400, Vietnam.
T Ngan GiangVinmec Research Institute of Stem Cell and Gene Technology, College of Health Sciences, Vin University, Vinhomes Ocean Park, Gia Lam District, Hanoi, 12400, Vietnam.
Nicholas ForsythUniversity of Aberdeen, King's College, Aberdeen, AB24 3FX, UK.
Van T HoangVinmec Research Institute of Stem Cell and Gene Technology, College of Health Sciences, Vin University, Vinhomes Ocean Park, Gia Lam District, Hanoi, 12400, Vietnam. van.ht@vinuni.edu.vn.
Liem Nguyen ThanhVinmec Research Institute of Stem Cell and Gene Technology, College of Health Sciences, Vin University, Vinhomes Ocean Park, Gia Lam District, Hanoi, 12400, Vietnam. liem.nt@vinuni.edu.vn.

Funding

Tập đoàn Vingroup - Công ty CP PRO2178
6 · The paper itself

Abstract

Extracellular vesicles (EVs) hold great promise as regenerative therapeutics due to their roles in intercellular communication and tissue repair. This study aimed to assess the safety of EVs derived from human mesenchymal stem cells (MSCs) obtained from both umbilical cord (UC-MSC-EVs) and adipose tissue (AD-MSC-EVs) sources, which were manufactured under xeno- and serum-free conditions and primed with 5% O2. EVs from neither source caused vascular or muscular stimulation in New Zealand rabbits. Systemic hypersensitivity tests revealed that neither UC-MSC-EVs nor AD-MSC-EVs triggered significant changes in allergic and immune responses or hematological parameters in the animals, highlighting their biocompatibility and safety when administered systemically. Furthermore, acute toxicity test using Swiss mice showed all mice survived without any signs of acute toxicity after intravenous injection of both types of EVs at very high doses (up to 10,000 µg/kg of body weight). In addition, subchronic toxicity examination in Wistar rats revealed that repeated injections of neither UC-MSC-EVs nor AD-MSC-EVs (50–150 µg/animal) affected hematological indices or the functions of the liver, kidney, or spleen. Collectively, our findings provide strong evidence that both UC-MSC-EVs and AD-MSC-EVs manufactured under xeno- and serum-free conditions and primed with 5% O2 are safe for potential therapeutic use. These results contribute to the growing body of evidence supporting the safety of physoxic MSC-derived EVs as therapeutic drugs, confirming their potential for applications in regenerative medicine.

Indexed as

Adipose TissueExtracellular VesiclesMesenchymal Stem CellsUmbilical CordAnimalsHumansMaleMiceRabbitsRatsRats, WistarAcute toxicityExtracellular vesicleMesenchymal stem cellsSafetySubchronic toxicitySystemic hypersensitivityVascular and muscular stimulation

Identifiers

PMID41102301
PMCPMC12533028

What OpenQuestion holds

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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.