NEW early-phase medical information recommend that eye drops derived from umbilical twine mesenchymal stem cells (MSCs) could provide a novel therapy possibility for sufferers with refractory dry eye illness (DED), together with these with Sjögren’s syndrome who’ve restricted responses to present therapies.
On this first-in-human, potential pilot research, researchers evaluated the security and preliminary efficacy of topical MSC eye drops in sufferers with extreme, treatment-resistant dry eye. Whereas MSC-based therapies have beforehand been explored by means of ocular injections, this research is the primary to evaluate MSCs delivered by way of eye drops, a route thought of extra sensible and patient-friendly for persistent ocular situations.
Testing a Novel Topical Remedy
The open-label, single-arm trial enrolled 16 sufferers, together with 11 with non-Sjögren’s dry eye (NSDE) and 5 with Sjögren’s syndrome–related dry eye (SSDE). All individuals acquired MSC eye drops twice day by day for 2 weeks and have been adopted at 4 weeks and once more at 12 months after therapy.
Scientific efficacy was assessed utilizing each patient-reported and goal measures, together with the ocular floor illness index (OSDI), tear meniscus top, non-invasive tear break-up time, Schirmer I check scores, and corneal fluorescein staining. Further assessments examined meibomian gland perform, lipid layer high quality, and conjunctival redness. Security was monitored all through the research interval.
Enhancements in Tear Manufacturing and Ocular Floor Well being
Following therapy, sufferers in each NSDE and SSDE teams skilled vital enhancements in a number of key medical parameters. Notably, tear manufacturing elevated, as mirrored by larger Schirmer check values and tear meniscus top, alongside lowered meibomian gland obstruction. Enhancements in signs and tear movie stability have been extra pronounced in sufferers with non-Sjögren’s dry eye, though sufferers with Sjögren’s syndrome additionally demonstrated measurable profit.
Importantly, no severe opposed occasions have been reported throughout therapy or long-term follow-up, supporting a beneficial preliminary security profile for topical MSC administration.
Alerts of Immune Modulation
Past medical outcomes, the research explored potential organic mechanisms. Tear evaluation revealed vital reductions in inflammatory cytokines interleukin-6 and interleukin-17A after therapy, alongside elevated ranges of MUC5AC, a mucin important for tear movie stability. Proteomic analyses additional recommended that MSC eye drops could exert their results by suppressing irritation pushed by T helper 17 cells, a pathway implicated in each Sjögren’s syndrome and extreme dry eye.
Trying Forward
The authors describe this research as an exploratory step relatively than definitive proof, emphasising the small pattern measurement and lack of a management group. Nonetheless, the mixture of symptomatic enchancment, goal ocular floor adjustments, and beneficial security indicators positions MSC eye drops as a probably transformative method for refractory dry eye illness.
Bigger, randomised managed trials will now be wanted to substantiate efficacy, evaluate outcomes with present remedies, and outline which affected person subgroups could profit most. If validated, MSC-based eye drops may characterize a brand new therapeutic avenue for sufferers whose dry eye stays troublesome to regulate with present choices.
Reference
Zhang D et al. A primary-in-human, potential pilot trial of umbilical cord-derived mesenchymal stem cell eye drops remedy for sufferers with refractory non-Sjögren’s and Sjögren’s syndrome dry eye illness. Stem Cell Res Ther. 2025;16(1):202.
