Characteristics of Extracellular Vesicles and Preclinical Testing Considerations Prior to Clinical Applications
Yoo MH., Lee AR., Moon KS.
Narrative Review, published in Biomedicines (2022) — summary generated from the PubMed abstract.
Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Narrative Review
- Journal
- Biomedicines (2022)
- Reported sample size
- —
- Source database
- Europe PMC
- PMID
- 35453619
- PMCID
- PMC9030546
- DOI
- 10.3390/biomedicines10040869
- Citations
- 32
Abstract (original English)
Cell therapy products have significant limitations, such as storage instability, difficulties with transportation, and toxicity issues such as tumorigenicity and immunogenicity. Extracellular vesicles (EVs) secreted from cells show potential for therapeutic agent development. EVs have not been widely examined as investigational drugs, and non-clinical studies for the clinical approval of EV therapeutic agents are challenging. EVs contain various materials, such as DNA, cellular RNA, cytokines, chemokines, and microRNAs, but do not proliferate or divide like cells, thus avoiding safety concerns related to tumorigenicity. However, the constituents of EVs may induce the proliferation of normal cells; therefore, the suitability of vesicles should be verified through non-clinical safety evaluations. In this review, the findings of non-clinical studies on EVs are summarized. We describe non-clinical toxicity studies of EVs, which should be useful for researchers who aim to develop these vesicles into therapeutic agents. A new method for evaluating the immunotoxicity and tumorigenicity of EVs should also be developed.
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
- • This is a narrative review: it collects no new patient data and does not systematically appraise evidence quality.
Evidence level
Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.
How we grade evidenceBrowse all related research
Filter the research library by this study's title keywords, author, or publication year.