Program in Public Health, University of California Irvine, Irvine, California, USA; Department of Health, Society and Behavior, University of California Irvine, Irvine, California, USA; Sue and Bill Gross Stem Cell Research Center, University of California Irvine, Irvine, California, USA; Department of Family Medicine, University of California Irvine, Irvine, California, USA.
Program in Public Health, University of California Irvine, Irvine, California, USA.
Cytotherapy. 2024 Apr;26(4):393-403. doi: 10.1016/j.jcyt.2024.01.001. Epub 2024 Feb 8.
The goal of this study was to analyze online marketing representations made by 300 US businesses selling allogeneic perinatal stem cell products. The study was conducted after a period of enforcement discretion by the US Food and Drug Administration (FDA).
Data mining and content analysis were used to identify, analyze and categorize marketing claims made on the websites of 300 businesses selling perinatal stem cell interventions.
The study identified types of perinatal interventions companies advertised, geographic locations of clinics selling such products, types of companies operating in this space, diseases and injuries such businesses claim to treat, prices companies charge for such interventions, brand names of advertised perinatal cell products and identities of suppliers.
A substantial number of US businesses market unapproved perinatal stem cell products for various indications. This widespread commercial activity occurred following the conclusion of a period of enforcement discretion by the FDA and suggests the need for more robust and comprehensive regulatory responses to businesses selling unapproved perinatal stem cell products.
本研究旨在分析 300 家销售异体围产干细胞产品的美国企业在网上进行的营销宣传。该研究是在美国食品和药物管理局（FDA）实行一段时间的执法自由裁量权之后进行的。
本研究采用数据挖掘和内容分析方法，对 300 家销售围产干细胞干预措施的企业网站上的营销宣传进行识别、分析和分类。
本研究确定了企业宣传的围产干预措施类型、销售此类产品的诊所的地理位置、该领域经营的企业类型、企业声称可治疗的疾病和损伤、企业对这类干预措施收取的费用、宣传的围产细胞产品的品牌名称以及供应商的身份。
大量的美国企业针对各种适应症销售未经批准的围产干细胞产品。这种广泛的商业活动发生在美国 FDA 结束执法自由裁量权之后，这表明需要对销售未经批准的围产干细胞产品的企业采取更有力和全面的监管措施。
