Evidence map›Paper›PMID 39112776›Full record

ReviewPharmaceutical research2024

Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles.

Yoshinobu Takakura, Rikinari Hanayama, Kazunari Akiyoshi, Shiroh Futaki, Kyoko Hida, Takanori Ichiki, Akiko Ishii-Watabe, Masahiko Kuroda, Kazushige Maki, Yasuo Miura and 5 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Pharmaceutical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 110 papers.

0numbers the graph read from it
0cells of the map it votes in
110citing 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

110 citing papers in PubMed.

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50 more citing papers are in PubMed but not listed here.

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

15 authors.

Yoshinobu TakakuraDepartment of Biopharmaceutics and Drug Metabolism, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan. takakura@pharm.kyoto-u.ac.jp.
Rikinari HanayamaWPI Nano Life Science Institute (NanoLSI), Kanazawa University, Kanazawa, Japan. hanayama@med.kanazawa-u.ac.jp.ORCID http://orcid.org/0000-0003-2102-3386
Kazunari AkiyoshiDepartment of Polymer Chemistry, Graduate School of Engineering, Kyoto University, Kyoto, Japan.
Shiroh FutakiInstitute for Chemical Research, Kyoto University, Kyoto, Japan.
Kyoko HidaVascular Biology and Molecular Biology, Faculty of Dental Medicine, Hokkaido University, Sapporo, Japan.
Takanori IchikiDepartment of Materials Engineering, School of Engineering, The University of Tokyo, Bunkyō, Japan.
Akiko Ishii-WatabeDivision of Biological Chemistry and Biologicals, National Institute of Health Sciences, Kawasaki, Japan.
Masahiko KurodaDepartment of Molecular Pathology, Tokyo Medical University, Shinjuku, Japan.
Kazushige MakiPharmaceuticals and Medical Devices Agency, Chiyoda-ku, Japan.
Yasuo MiuraDepartment of Transfusion Medicine and Cell Therapy, School of Medicine, Fujita Health University, Toyoake, Japan.
Yoshiaki OkadaDepartment of Transfusion Medicine and Cell Transplantation, Saitama Medical University Hospital, Kawagoe, Japan.
Naohiro SeoDepartment of Bioengineering, School of Engineering, The University of Tokyo, Bunkyō, Japan.
Toshihide TakeuchiLife Science Research Institute, Kindai University, Higashi-osaka, Japan.
Teruhide YamaguchiKanazawa Institute of Technology, Nonoichi, Japan.
Yusuke YoshiokaDepartment of Molecular and Cellular Medicine, Institute of Medical Science, Tokyo Medical University, Shinjuku, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Extracellular vesicles (EVs) serve as an intrinsic system for delivering functional molecules within our body, playing significant roles in diverse physiological phenomena and diseases. Both native and engineered EVs are currently the subject of extensive research as promising therapeutics and drug delivery systems, primarily due to their remarkable attributes, such as targeting capabilities, biocompatibility, and low immunogenicity and mutagenicity. Nevertheless, their clinical application is still a long way off owing to multiple limitations. In this context, the Science Board of the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has conducted a comprehensive assessment to identify the current issues related to the quality and safety of EV-based therapeutic products. Furthermore, we have presented several examples of the state-of-the-art methodologies employed in EV manufacturing, along with guidelines for critical processes, such as production, purification, characterization, quality evaluation and control, safety assessment, and clinical development and evaluation of EV-based therapeutics. These endeavors aim to facilitate the clinical application of EVs and pave the way for their transformative impact in healthcare.

Indexed as

Extracellular VesiclesQuality ControlAnimalsDrug Delivery SystemsHumansclinical trialsextracellular vesiclesquality characterizationsafety evaluationtherapeutic products

Identifiers

PMID39112776
PMCPMC11362369

What OpenQuestion holds

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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.