Dry eye disease (DED) affects up to 50% of the U.S. population, costing the nation’s health care system approximately $50 billion annually. A team recently completed a clinical trial using corneal epithelial stem cells to improve outcomes for DED patients.
Many treatments for DED are currently available, including ocular lubricants, topical antibiotics, topical corticosteroids, scleral contact lenses that are designed to sharpen vision and provide comfort for dry eyes, and many others. Despite this menu of DED treatments options, Hironmoy Das, Ph.D., a professor of pharmaceutical sciences at the Texas Tech University Health Sciences Center (TTUHSC) Jerry H. Hodge School of Pharmacy, said clinicians and researchers have continued to see a need to develop safer and more effective treatment options.
With that in mind, Das developed a technology derived from corneal epithelial stem cells to improve outcomes for DED patients. Corneal epithelial stem cells are located and obtained soley from the limbus, which is the area of the eye where the cornea and conjunctiva intersect. The results of their clinical trial, «Corneal Epithelial Stem Cell Supernatant in the Treatment of Severe Dry Eye Disease: A Pilot Study,» were published July 16 in The Journal of Clinical Ophthalmology.
The research team also included Sloan W. Rush, M.D., from the Panhandle Eye Group in Amarillo, Texas, who led the clinical trial, and Jennifer Chain, Ph.D., from the Oklahoma Blood Institute in Oklahoma City.
Other than a few treatments that necessitate the use of invasive surgery or employ biologic material that is not specifically intended for the ocular surface, there currently are no studies in which a safe and impactful therapeutic biologic agent for DED is reported. Das said that makes his team’s clinical study unique because it explores for the first time a novel, patient-delivered topical application derived from expanded human corneal epithelial stem cells for treating severe DED in humans. Normally, stem cells are injected into a patient, but in this case, rather than injecting the stem cells, Das’ team made a product from the stem cells that is applied like eye drops.
«It is very exciting because this is the first time my research has led to a clinical trial,» Das said. «Laboratory investigators cannot perform clinical trials, so we depend on clinicians like Dr. Rush.»
Because there were no Good Manufacturing Practice (GMP) facilities available in the Amarillo, Texas area at the time the study began, Das and Rush collaborated with the Oklahoma Blood Institute. GMP facilities adhere to a specific and detailed system of regulations from the U.S. Food and Drug Administration (FDA) designed to ensure products are manufactured consistently and meet rigorous quality control standards.
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Materials provided by Texas Tech University Health Sciences Center. Original written by Mark Hendricks. Note: Content may be edited for style and length.