Stem Cells for Corneal Disease

Early trials highlight promise of stem cells in treating dry eye disease. Dermot McGrath reports from the 39th Congress of the ESCRS in Amsterdam. The regenerative properties of mesenchymal stem cells (MSCs) may offer a safe and effective treatment for certain types of dry eye disease based on evidence from initial clinical trials, new research suggests. “The injection of allogeneic adipose-derived MSCs (ASCs) into the lacrimal gland seems to be a safe and well-tolerated treatment for severe aqueous deficient dry eye disease (ADDE),” reported Michael Møller-Hansen MD. Dr Møller-Hansen gave a broad overview of recent research carried out at the University of Copenhagen, Denmark, using ASCs as a potential treatment for dry eye disease. During the past decade, there has been an increasing interest in using stem-cell therapy to treat a wide range of different pathologies, including ocular diseases, Dr Møller-Hansen noted. MSCs offer several advantages in therapeutic use thanks to their regenerative and anti-inflammatory properties. “We see a lot of patients with dry eyes in the clinic. When I first started in ophthalmology, I was surprised to see the effect dry eye disease had on their quality of life. It would be good to be able to contribute to improving that situation for these patients,” he said. Dr Møller-Hansen cited two recent studies in canines with keratoconjunctivitis sicca that underscored the potential of MSCs to offer safe and durable treatment. “One study showed that a single injection of MSCs had an effect on these canines up to 12 months after one treatment, and the other study reported no systemic or local complications related to the treatment,” he said. Moving to human studies, Dr Møller-Hansen reported the results of an open-label clinical trial conducted by their research group in Copenhagen in which seven patients with ADDE received one transconjunctival injection of allogeneic ASCs into the lacrimal gland in one eye. The primary endpoint of the study was treatment-related adverse events, while secondary measures included Ocular Surface Disease Index (OSDI), tear osmolarity, tear film break-up time (TBUT), corneal staining (Oxford grade), and Schirmer’s I test. No adverse events related to the study treatment occurred at any of the follow-up visits, Dr Møller-Hansen reported. The most frequent adverse effects were observed immediately after treatment and included a temporary increase in ocular discomfort and temporary periorbital oedema. In terms of secondary outcomes, the mean OSDI score decreased from 58.9 at baseline to 34.1 four months after treatment. The other objective measurements of dry eye indicators showed a statistically significant improvement in treated eyes as mean tear osmolarity decreased from 312.9 to 291.6, mean TBUT increased from 3.7 to 7.1, and the mean Schirmer’s I test increased from 4.6 to 8.1/5 min. Based on these positive results, the team at the University of Copenhagen has almost completed enrolment for a randomised placebo-controlled trial (AMASS) aimed at elucidating the therapeutic effect of allogeneic ASCs in 40 patients with dry eyes due to Sjögren’s syndrome. “We want to test the hypothesis that injection of allogeneic ASCs into the lacrimal gland increases tear production and reduces inflammation resulting in increased ocular comfort compared to placebo. We have enrolled 36 out of the 40 patients so far and hope to have the final results of the 12-month follow-up towards the end of 2022,” Dr Møller-Hansen concluded. Michael Møller-Hansen MD is a researcher at the Department of Ophthalmology, Rigshospitalet-Golstrup, University of Copenhagen, Denmark. michael.moeller-hansen@regionh.dk