Kalavar Meghana, Lovett Eric A, Nicholas Matthew P, Ross-Hirsch Adam, Nirwan Rajinder S, Sridhar Jayanth, Patel Shriji, Flynn Harry W, Albini Thomas A, Kuriyan Ajay E
Havener Eye Institute, Ohio State University Wexner Medical Center (M.K.), Columbus, Ohio, USA.
Jacobs School of Medicine and Biomedical Sciences, University at Buffalo (E.A.L.), Buffalo, New York, USA.
Am J Ophthalmol. 2024 Nov;267:135-141. doi: 10.1016/j.ajo.2024.06.014. Epub 2024 Jun 15.
To assess the scope of U.S.-based companies advertising and administering non-Federal Drug Administration (FDA) approved cell-based therapy (herein called NFACT) for ocular conditions based on information from companies' public websites after the FDA's legal actions against specific NFACT clinics in 2018 and 2019. Current findings are compared to previously published data from 2017.
Trend study looking at U.S.-based companies that use direct-to-consumer marketing and have websites advertising therapy for ocular conditions.
A systematic and extensive keyword-based Internet search was utilized to identify, document, and analyze U.S. business websites offering NFACT for ocular conditions as of August 2022. Main outcomes measured include, clinic locations, marketed ocular conditions, types of NFACT offered, source of stem cells used, routes of administration, and treatment costs.
From the prior analysis in 2017 to the 2019 analysis, there was a decrease in the number of NFACT clinics from 76 to 62 and companies from 40 to 39. Given the concerning persistence of NFACTs in August 2019 an additional analysis was performed in 2022 which showed a drastic decrease in NFACT clinics from 62 in 2019 to 18 in 2023 and from 39 companies to 13 in 2023. In both 2019 and 2022, the most commonly referenced ocular condition was age-related macular degeneration (2019-72%, 2022-92%). The state with the most clinics was in Texas (2019-12; 2022-5). Autologous adipose-derived stem cells were the most common cell type used in both analyses.
In 2019 U.S.-based direct-to-consumer companies marketing NFACT persisted despite (1) a lack of high-quality clinical evidence supporting the efficacy of these procedures, (2) the association of some of these treatments with severe vision loss, and (3) increasing FDA oversight and recent legal action. In 2022 the number of clinics and companies decreased, but their persistence is a reminder that continued concern is necessary and ophthalmic associations need to continue advocacy efforts to protect patients from these potentially predatory organizations.
基于美国食品药品监督管理局（FDA）在2018年和2019年对特定非FDA批准的细胞疗法诊所采取法律行动后，从公司公开网站获取的信息，评估美国公司针对眼部疾病宣传和管理非FDA批准的细胞疗法（以下简称NFACT）的情况。将当前研究结果与2017年之前发表的数据进行比较。
对使用直接面向消费者营销且有网站宣传眼部疾病疗法的美国公司进行趋势研究。
截至2022年8月，利用基于关键词的系统且广泛的互联网搜索来识别、记录和分析提供针对眼部疾病的NFACT的美国商业网站。主要测量结果包括诊所位置、宣传的眼部疾病、提供的NFACT类型、所用干细胞来源、给药途径和治疗费用。
从2017年的先前分析到2019年的分析，NFACT诊所数量从76家减少到62家，公司数量从40家减少到39家。鉴于2019年8月NFACT持续存在的情况令人担忧，2022年又进行了一次分析，结果显示NFACT诊所数量从2019年的62家急剧减少到2023年的18家，公司数量从39家减少到2023年的13家。在2019年和2022年，最常提及的眼部疾病都是年龄相关性黄斑变性（2019年为72%，2022年为92%）。诊所数量最多的州是得克萨斯州（2019年为12家；2022年为5家）。在两次分析中，自体脂肪来源的干细胞都是最常用的细胞类型。
2019年，尽管（1）缺乏支持这些程序有效性的高质量临床证据，（2）其中一些治疗与严重视力丧失有关，（3）FDA监管加强且近期采取了法律行动，但美国直接面向消费者营销NFACT的公司仍持续存在。2022年诊所和公司数量减少了，但它们的持续存在提醒人们仍需持续关注，眼科协会需要继续开展宣传工作，以保护患者免受这些潜在掠夺性组织的侵害。
