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

IF 2.4 4区医学 Q4 CELL & TISSUE ENGINEERING

Regenerative medicine Pub Date : 2023-11-01 Epub Date: 2023-10-23 DOI:10.2217/rme-2023-0117

Leigh Turner, Juan Ramon Martinez, Shemms Najjar, Thevin Rajapaksha Arachchilage, Victoria Sahrai, Jia Chieng Wang

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引用次数: 0

Abstract

Aim: 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. Methods: 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. Results: 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. Conclusion: 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.

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从事所谓干细胞治疗和外泌体疗法直接面向消费者营销的美国企业提出的监管要求。

目的：本研究调查了从事所谓干细胞疗法和干细胞衍生外泌体产品直接面向消费者的在线营销的美国企业是否对这些干预措施的监管状况提出了索赔。方法：我们使用数据挖掘和公司网站的内容分析来检查美国企业营销干细胞治疗和外泌体治疗的监管相关陈述。结果：超过三分之二的此类企业没有明确表示其营销产品的监管状况。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关于这些干预措施法律地位的陈述。结论：缺乏关于干细胞干预和外泌体产品监管状况的信息，以及使用了关于许多产品监管状况似乎不准确的信息，这可能会使客户做出知情的健康相关决策变得复杂。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Regenerative medicine 医学-工程：生物医学

CiteScore

4.20

自引率

3.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function*. Since 2006, Regenerative Medicine has been at the forefront of publishing the very best papers and reviews covering the entire regenerative medicine sector. The journal focusses on the entire spectrum of approaches to regenerative medicine, including small molecule drugs, biologics, biomaterials and tissue engineering, and cell and gene therapies – it’s all about regeneration and not a specific platform technology. The journal’s scope encompasses all aspects of the sector ranging from discovery research, through to clinical development, through to commercialization. Regenerative Medicine uniquely supports this important area of biomedical science and healthcare by providing a peer-reviewed journal totally committed to publishing the very best regenerative medicine research, clinical translation and commercialization. Regenerative Medicine provides a specialist forum to address the important challenges and advances in regenerative medicine, delivering this essential information in concise, clear and attractive article formats – vital to a rapidly growing, multidisciplinary and increasingly time-constrained community. Despite substantial developments in our knowledge and understanding of regeneration, the field is still in its infancy. However, progress is accelerating. The next few decades will see the discovery and development of transformative therapies for patients, and in some cases, even cures. Regenerative Medicine will continue to provide a critical overview of these advances as they progress, undergo clinical trials, and eventually become mainstream medicine.