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美国从事所谓干细胞治疗和外泌体疗法的直接面向消费者营销的企业提出的监管声明。

Regulatory claims made by US businesses engaged in direct-to-consumer marketing of purported stem cell treatments and exosome therapies.

机构信息

Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Room 3543, Irvine, CA 92697-3957, USA.

Department of Health, Society, & Behavior, University of California Irvine, Irvine, CA 92697-3957, USA.

出版信息

Regen Med. 2023 Nov;18(11):857-868. doi: 10.2217/rme-2023-0117. Epub 2023 Oct 23.

DOI:10.2217/rme-2023-0117
PMID:37867326
Abstract

This study investigated whether US businesses engaged in direct-to-consumer online marketing of purported stem cell therapies and stem cell-derived exosome products made claims concerning the regulatory status of these interventions. We used data mining and content analysis of company websites to examine regulatory-related representations made by US businesses marketing stem cell treatments and exosome therapies. More than two thirds of such businesses did not make explicit representations about the regulatory status of their marketed products. Businesses that made claims about the regulatory status of the stem cell and exosome products they sold used range of representations concerning the legal standing of these interventions. The absence of information addressing the regulatory status of stem cell interventions and exosome products and the use of what appeared to be inaccurate information concerning the regulatory status of numerous products likely complicates efforts by customers to make informed health-related decisions.

摘要

本研究调查了美国企业是否在直接面向消费者的在线营销中对所谓的干细胞疗法和干细胞衍生的外泌体产品做出了有关这些干预措施监管状况的声明。我们使用数据挖掘和公司网站的内容分析来检查营销干细胞治疗和外泌体疗法的美国企业的监管相关陈述。超过三分之二的此类企业没有明确表示其上市产品的监管状况。声称其销售的干细胞和外泌体产品的监管状况的企业使用了一系列有关这些干预措施法律地位的陈述。缺乏有关干细胞干预措施和外泌体产品监管状况的信息,以及使用似乎不准确的信息来描述众多产品的监管状况,这可能会使客户在做出与健康相关的知情决策时感到困惑。

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