The Food and Drug Administration has succeeded in its efforts to stop a company that operates two Florida-based stem-cell clinics, including one where three patients went blind after receiving treatments to cure their age-related macular degeneration, from peddling its adipose-tissue-derived stem-cell products. Last month, a federal district court granted the agency’s request for a permanent injunction against the company.
The entrance to the U.S. Stem Cell clinic in Sunrise, Fla., where three patients went blind after intravitreal stem-cell injections. (Image courtesy of Jim Rassol / South Florida Sun Sentinel /Polaris.)
Judge Ursula Ungaro’s order stops U.S. Stem Cell Clinic locations in Weston and Sunrise, along with the company’s chief scientific officer Kristin Comella, PhD, from manufacturing or distributing any stromal vascular fraction products until they come into compliance with the law, the FDA said.
Three patients went blind after they received intravitreal injections of autologous adipose tissue-derived stem cells at the Sunrise clinic, as documented in a March 2017 New England Journal of Medicine article by Ajay E. Kuriyan, MD, Thomas Albini, MD, and colleagues.1 They reported the patients’ vision loss was associated with ocular hypertension, hemorrhagic retinopathy, vitreous hemorrhage, combined traction and rhegmatogenous retinal detachment or lens dislocation, and that their visual acuity ranged from 20/200 to no light perception one year after receiving treatment. (Drs. Kuriyan and Albini reported on their findings about cell therapy clinics in the January/February 2019 issue of Retina Specialist.)
In 2018, the FDA issued the company a warning letter and filed for the permanent injunction. During the court proceedings, The New York Times reported Dr. Comella had argued that the stem-cell extracts injected into the patients’ eyes contained the patients’ own cells and so were not a drug and, hence, were exempt from FDA regulation.
The FDA hopes this action sends a warning to other stem-cell clinics that have been operating outside the agency’s purview. “Today’s action by Judge Ungaro is significant and sends a strong message to others manufacturing violative stem-cell products,” acting FDA Commissioner Norman E. Sharpless, MD, and director of the center for biologics evaluation and research
Peter Marks, MD, PhD, said in a joint statement. They said the agency is going to continue to issue warning letters and bring court cases against unauthorized stem-cell clinics. Over the past year, the FDA has issued 46 “regulatory correspondences,” which include warning letters. One court case is ongoing.
In the meantime, the FDA says it will continue to work with legitimate stem-cell providers through its expedited review programs and engagement with manufacturers to provide informal and non-binding evaluations of cell- and tissue-based products.
1. Kuriyan AE, Albini TA, Townsend JH, et al. Vision loss after Intravitreal injection autologous "stem cells" for AMD. N Engl J Med. 2017;376:1047-1053.
More evidence of lipid-lowering drugs’ benefits in diabetic retinal disease
A large U.S. population study has provided further evidence that patients with diabetes taking statins have lower rates of both nonproliferative and proliferative diabetic retinopathy as well as diabetic macular edema, according to an article in press in the American Journal of Ophthalmology.1
The study authors, led by Darius M. Moshfeghi, MD, at the Byers Eye Institute at Stanford University, analyzed 269,782 patients in the
Truven MarketScan Commercial Claims and Encounters database, 37 percent (99,233) of whom were on lipid-lowering therapy. The rates of diabetic retinal disease diagnosis or related treatment were approximately 10 percent lower in the treated population, 6 percent vs. 6.5 percent (p<0.01). The study considered patients with a diagnosis of NPDR, PDR or DME, or a history of treatment for retinal disease—either intravitreal injection, pars plana vitrectomy or laser—following a diagnosis of diabetes as the affected population.
Digging deeper, the researchers found that patients who were taking lipid-lowering drugs before they were diagnosed with type 2 diabetes had statistically significant lower risk of progressing on to any retinopathy diagnosis or receiving any treatment for retinopathy—lower by 40 and 19 percent, respectively.
The study acknowledged earlier evidence of the association between hyperlipidemia and high triglyceride levels and retinopathy, as well as the beneficial effects of lipid-lower drugs on retinal disease and related treatment, most notably recent studies from Japan and Taiwan.2,3 The aim of the most recent study was to perform a real-world analysis of a large database in a diverse population.
1. Vail D, Callaway NF, Ludwig CA, Saroj N, Moshfeghi DM. Lipid-lowering medications are associated with lower risk of retinopathy and ophthalmic interventions among U.S. patients with diabetes. Am J Ophthalmol. 2019 June 10. [epub ahead of print]
2. Kawasaki R, Konta T, Nishida K. Lipid-lowering medication is associated with decreased risk of diabetic retinopathy and the need for treatment in patients with type 2 diabetes: A real-world observational analysis of a health claims database. Diabetes Obes Metab. 2018; 20:2351-2360
3. Kang EY, Chen TH, Garg SJ, et al. Association of statin therapy with prevention of vision-threatening diabetic retinopathy. JAMA Ophthalmol. 2019 Jan 10. [epub ahead of print]