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本文引用的文献

1
Businesses marketing purported stem cell treatments and exosome therapies for COVID-19: An analysis of direct-to-consumer online advertising claims.针对 COVID-19 的所谓干细胞治疗和外泌体疗法的商业营销：对直接面向消费者的在线广告声明的分析。
Stem Cell Reports. 2023 Nov 14;18(11):2010-2015. doi: 10.1016/j.stemcr.2023.09.015. Epub 2023 Oct 26.
2
Safety and efficacy claims made by US businesses marketing purported stem cell treatments and exosome therapies.美国企业在推销所谓的干细胞治疗和外泌体疗法时所做的安全性和疗效声明。
Regen Med. 2023 Oct;18(10):781-793. doi: 10.2217/rme-2023-0118. Epub 2023 Oct 5.
3
FedEx for your cells: this biological delivery service could treat disease.细胞的联邦快递：这种生物递送服务可以治疗疾病。
Nature. 2023 Sep;621(7979):462-464. doi: 10.1038/d41586-023-02906-w.
4
Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes.揭示灰色地带：绘制全球直接面向消费者的基于分泌组、细胞外囊泡和外泌体的干预措施提供业务的全景图。
Stem Cell Res Ther. 2023 May 4;14(1):111. doi: 10.1186/s13287-023-03335-2.
5
Development of extracellular vesicle-based medicinal products: A position paper of the group "Extracellular Vesicle translatiOn to clinicaL perspectiVEs - EVOLVE France".基于细胞外囊泡的药物产品的开发：“细胞外囊泡转化为临床观点 - EVOLVE 法国”小组的立场文件。
Adv Drug Deliv Rev. 2021 Dec;179:114001. doi: 10.1016/j.addr.2021.114001. Epub 2021 Oct 19.

迫切需要制定明确和简洁的基于外泌体的干预措施法规。

The urgent need for clear and concise regulations on exosome-based interventions.

机构信息

Uehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application (CiRA), Kyoto University, Sakyo-ku, Kyoto 606-8507, Japan; Institute for the Advanced Study of Human Biology (WPI-ASHBi), KUIAS, Kyoto University, Sakyo-ku, Kyoto 606-8501, Japan.

Graduate School of Public Health, Shizuoka Graduate University of Public Health, Aoi-ku, Shizuoka 420-0881, Japan.

出版信息

Stem Cell Reports. 2024 Nov 12;19(11):1517-1519. doi: 10.1016/j.stemcr.2024.09.008. Epub 2024 Oct 24.

DOI:10.1016/j.stemcr.2024.09.008
PMID:39454583
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11589178/
Abstract

Turner and colleagues recently argued that countries with unclear laws and regulations regarding stem cells, exosomes, and other regenerative medicine products should develop and enforce more comprehensive regulatory structures. We fully agree with this opinion and discuss that failure to do so may lead to troubling predicaments, such as the Japanese cases, where patients are at risk of serious complications or even death.

摘要

特纳及其同事最近认为，对于干细胞、外泌体和其他再生医学产品的法律法规不明确的国家，应制定并执行更全面的监管结构。我们完全同意这一观点，并讨论了不这样做可能导致的麻烦困境，例如日本的案例，患者有发生严重并发症甚至死亡的风险。