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Patient Understanding of Non-Approved Stem Cell Therapies for Retinal Disease.

Published:November 02, 2021DOI:https://doi.org/10.1016/j.oret.2021.10.012
      The use of Stem Cell Therapy (SCT) in ocular diseases such as age-related macular degeneration (AMD) is currently being investigated in U.S. Food and Drug Administration (FDA)-approved trials.
      • Kuriyan A.E.
      • Albini T.A.
      • Townsend J.H.
      • et al.
      Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD.
      However, many clinics in the U.S. have adopted this therapy without an appropriate Investigational New Drug Application (IND) from the FDA by using adipose-based stem cells, which are easy to obtain and therefore easy to use in a non-approved, clinical setting.
      • Kuriyan A.E.
      • Albini T.A.
      • Townsend J.H.
      • et al.
      Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD.
      The dangers of non-approved SCT were presented in a case study of three patients who received adipose-based SCT from stem cell clinics and later presented with devastating vision loss.
      • Kuriyan A.E.
      • Albini T.A.
      • Townsend J.H.
      • et al.
      Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD.
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      References

        • Kuriyan A.E.
        • Albini T.A.
        • Townsend J.H.
        • et al.
        Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD.
        N Engl J Med. 2017; 376: 1047-1053
      1. FDA Warns About Stem Cell Therapies. 2019; https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies. Accessed May 30, 2021.

      2. Internet hawkers of stem cell therapies raising red flags. Ophthalmology Times; 2020. https://www.ophthalmologytimes.com/view/internet-hawkers-of-stem-cell-therapies-raising-red-flags.

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        • Kuriyan A.E.
        Assessing "Cell Therapy" Clinics Offering Treatments of Ocular Conditions using Direct-to-Consumer Marketing Websites in the United States.
        Ophthalmology. 2019; 126: 1350-1355