June 2020
Volume 61, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2020
Update on “Cell Therapy” Clinics Offering Treatments of Ocular Conditions using Direct-to-Consumer Marketing Websites in the United States
Author Affiliations & Notes
  • Adam Ross-Hirsch
    University of Rochester School of Medicine and Dentistry, Rochester, New York, United States
  • Matthew Nicholas
    Flaum Eye Institute, University of Rochester Medical Center, New York, United States
  • Rajinder Nirwan
    Flaum Eye Institute, University of Rochester Medical Center, New York, United States
  • Thomas Albini
    Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Florida, United States
  • Jayanth Sridhar
    Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Florida, United States
  • Harry W Flynn
    Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Florida, United States
  • Ajay E. Kuriyan
    Flaum Eye Institute, University of Rochester Medical Center, New York, United States
    Center for Visual Sciences, University of Rochester, New York, United States
  • Footnotes
    Commercial Relationships   Adam Ross-Hirsch, None; Matthew Nicholas, None; Rajinder Nirwan, None; Thomas Albini, None; Jayanth Sridhar, None; Harry Flynn, None; Ajay Kuriyan, None
  • Footnotes
    Support  Unrestricted grant from Research to Prevent Blindness (Flaum Eye Institute, University of Rochester Medical Center) and NIH P30 EY001319
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 802. doi:
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      Adam Ross-Hirsch, Matthew Nicholas, Rajinder Nirwan, Thomas Albini, Jayanth Sridhar, Harry W Flynn, Ajay E. Kuriyan; Update on “Cell Therapy” Clinics Offering Treatments of Ocular Conditions using Direct-to-Consumer Marketing Websites in the United States. Invest. Ophthalmol. Vis. Sci. 2020;61(7):802.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To assess the scope of U.S.-based businesses advertising and administering “cell therapy” for ocular conditions, based on information from businesses’ public websites. We compare the current findings to our published data from 2017.

Methods : We used a systematic and extensive keyword-based Internet search, identical to our previous study, to identify U.S. business websites offering “cell therapy” for ocular conditions as of August 2019. We analyzed website content to determine characteristics including clinic locations, marketed ocular conditions, types of “cell therapy” offered, routes of administration, and treatment costs.

Results : Since our 2017 analysis, 13 originally identified businesses removed all advertisements for ocular conditions, and 6 discontinued their URLs. During our repeat analysis, we identified 39 businesses (62 clinics total), including 14 newly-identified. All 39 businesses referenced ocular conditions, most commonly age-related macular degeneration (72%). Most clinics were in Texas (12), California (11), Florida (10), and Illinois (10). Texas accounted for the largest increase in clinics per state since our original analysis, while the number of clinics in California decreased by 48%. A range of cell sources and administration modalities were offered. Most websites did not specify fees. Most companies were affiliated with a credentialed physician. Of the 6 companies claiming involvement in clinical trials and “patient funded research”, only 2 were registered on ClinicalTrials.gov. Reference to FDA approval or other oversight was highly variable and often misleading.

Conclusions : U.S.-based direct-to-consumer businesses marketing non-FDA-approved “cell therapies” persist 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 regulatory oversight and recent legal action. Remaining well-informed regarding “cell therapy” marketing and administration practices will help ophthalmologists assist patients in interpreting advertisements and in avoiding costly and potentially harmful procedures. This counseling will be increasingly important as cell therapies enter well-designed clinical trials and possibly evidence-based clinical practice.

This is a 2020 ARVO Annual Meeting abstract.

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