Evidence map›Paper›PMID 40124467›Full record

ReviewRegenerative therapy2025

Guidance on the clinical application of extracellular vesicles.

Shuji Terai, Motohiro Asonuma, Ayuko Hoshino, Masahiro Kino-Oka, Takahiro Ochiya, Kiyoshi Okada, Yoji Sato, Yuki Takahashi, Morikuni Tobita, Atsunori Tsuchiya

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Regenerative therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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

17 citing papers in PubMed.

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  14. Article
  15. Tumor-derived extracellular vesicles: Bridging communication and next-generation theranostics.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2025
    Review
  16. Counting Copies, Making Medicines: A Roadmap for the MSC-EV-microRNAome.International journal of molecular and cellular medicine · 2025
    Article
  17. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Shuji TeraiDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Motohiro AsonumaVisiting Professor Juntendo University (Information System Headquarters), Japan.
Ayuko HoshinoSchool of Life Science and Technology, Tokyo Institute of Technology, Kanagawa, Japan.
Masahiro Kino-OkaDepartment of Biotechnology, Graduate School of Engineering, Osaka University, Osaka, Japan.
Takahiro OchiyaDepartment of Molecular and Cellular Medicine, Center for Future Medical Research, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan.
Kiyoshi OkadaX-innovation Committee for Health and Medical, Osaka University Graduate School of Medicine, Osaka, Japan.
Yoji SatoDivision of Drugs, National Institute of Health Sciences, Kanagawa, Japan.
Yuki TakahashiDepartment of Drug Delivery Research, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan.
Morikuni TobitaMedical Technology Innovation Center, Juntendo University, Tokyo, Japan.
Atsunori TsuchiyaDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Therapies using extracellular vesicles (EVs), exosomes, or cell culture supernatants containing EVs or exosomes (referred to as "EV therapies" in this Guidance) have garnered an increasing amount of interest. However, pharmaceutical products containing EVs as their main active ingredient are yet to receive regulatory approval. The "Basic points to consider regarding the preparation of extracellular vesicles and their clinical applications in Japan," was announced by the Japanese Society for Regenerative Medicine (JSRM) on March 10, 2021, with a specific focus on exosomes among EVs to promote high safety standards in this evolving field and facilitate the application of EV clinically. The Scientific Committee of the Pharmaceuticals and Medical Devices Agency and the Japanese Society for Extracellular Vesicles have issued reports and statements regarding treatment, resulting in a growing momentum toward treatment in Japan. This article summarized the basic items that should be recognized comprehensively for clinical practice in three categories: (1) risk profiling, (2) preparation (manufacturing) process and quality, and (3) verification of EVs checking items and effectiveness. This guideline will be revised in the future with technological innovations and new findings; nevertheless, it will serve as a guide for the development of treatments.

Indexed as

Clinical applicationExtracellular vesicleGuidance

Identifiers

PMID40124467
PMCPMC11930518

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.