Dry Eye Disease (DED) is a chronic condition characterized by insufficient tear production, tear film instability, and ocular surface inflammation. Symptoms include burning, itching, foreign body sensation, photophobia, and blurred vision. In cases resistant to conventional therapies, the discomfort can become particularly disabling.
A recent clinical trial tested for the first time the use of eye drops containing mesenchymal stem cells (MSCs) derived from umbilical cord tissue to treat refractory forms of dry eye, both non-Sjögren (NSDE) and Sjögren’s syndrome-associated (SSDE). Results are promising.
The Clinical Trial
-
Participants: 16 patients (11 with NSDE, 5 with SSDE).
-
Treatment: Bilateral instillation of MSC eye drops twice daily for two weeks.
-
Follow-up: Assessments at 4 weeks and 12 months.
Main Findings
-
Increased tear production: Significant improvements in Schirmer I Test and Tear Meniscus Height, especially in NSDE patients.
-
Improved tear film stability: Notable increase in Non-Invasive Break-Up Time (NIBUT), over 4 seconds on average in NSDE.
-
Symptom relief: Substantial reduction in Ocular Surface Disease Index (OSDI) scores, lasting up to 4 weeks in NSDE.
-
Better Meibomian gland function: Reduction of gland obstruction, contributing to more stable tears.
-
Anti-inflammatory effect: Decrease in pro-inflammatory cytokines (IL-6, IL-17A, CCL20, IL-23) and increase in MUC5AC, a protective mucin. Proteomic analysis confirmed modulation of Th17 activity.
-
Safety: No serious adverse events; only mild, transient discomforts were reported.
Conclusions
Umbilical cord MSC-based eye drops proved safe and potentially effective in refractory dry eye. Benefits were more evident in NSDE patients, but SSDE patients also experienced improvement, particularly in tear secretion and Meibomian gland function.
This study marks an important step toward regenerative therapies for dry eye, though larger randomized trials will be needed to validate efficacy and optimize treatment protocols.
Reference
Zhang D, Chen T, Liang Q, Feng X, Jiang J, Chen Z, Tang Y, Chu Y, Wang B, Hu K.
A first-in-human, prospective pilot trial of umbilical cord-derived mesenchymal stem cell eye drops therapy for patients with refractory non-Sjögren’s and Sjögren’s syndrome dry eye disease.
Stem Cell Research & Therapy. 2025 Apr 23;16(1):202. doi: 10.1186/s13287-025-04292-8.
PMID: 40269970 – PMCID: PMC12020048
