Abstract
Purpose :
Misinformation regarding non-Food and Drug Administration (FDA) sponsored, largely unproven, stem cell therapies (SCTs) for retinal disease may pose significant risks to patients. A survey was administered to patients with retinal disease to ascertain their baseline knowledge of SCTs.
Methods :
A prospective survey was administered to patients presenting to a retina clinic for dry age-related macular degeneration(AMD) or a variant of diagnoses requiring anti-VEGF therapy. Before clinical evaluation, patients completed a survey evaluating their knowledge about SCTs for retinal disease. Demographics, visual acuity (VA), and clinical diagnoses were also recorded. Visual impairment was classified in accordance with guidelines defined by the World Health Organization (WHO). Pearson chi-square tests for independence were used for gender and ethnicity comparisons.
Results :
There were 58 participants, 31(53.4%) of whom believed there were FDA-approved and commercially available SCTs for retinal disease (95% CI= 39.9%-66.1%). Thirty-eight (65.5%) patients believed all clinical trials found online were regulated by the FDA (95% CI= 51.9%-77.5%). A chi-square test of independence showed no significant association between patient responses and gender. However, Hispanic patients were more likely than non-Hispanic patients to believe there were current FDA approved SCTs commercially available (p =0.048) and to believe that all clinical trials found online are approved by the FDA (p=0.0006). Only 9 (15.8%) respondents were aware of risks associated with non-FDA approved SCTs for retinal disease (95% CI=7.3%-27.4%). Twenty-two (37.9%) respondents said they would consider SCT not approved by the FDA (95% CI=25.5%-51.6%).
Conclusions :
Confusion exists regarding the federal regulation of SCTs for retinal disease and Hispanic patients may be a population more vulnerable to misinformation regarding these unapproved therapies.
This is a 2021 ARVO Annual Meeting abstract.