Therapeutic Potential of Adipose-Derived Mesenchymal Stem Cells Transplantation into the Lacrimal Gland in Patients with Sjögren Syndrome.

[PURPOSE] This study evaluated the feasibility and effectiveness of autologous adipose-derived mesenchymal stem cell (ASC) transplantation into the lacrimal gland for treating aqueous-deficient dry eye disease (DED) associated with Sjögren syndrome.

[METHODS] Patients with Sjögren syndrome-related DED underwent autologous adipose tissue harvest via liposuction. ASCs were isolated, cultured, and injected into the lacrimal gland (volume ≤50% of estimated gland volume). Clinical evaluations- including Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), Oxford corneal staining, and Schirmer test I-were conducted at 1-, 4-, 16-, and 24-weeks after injection. Visual quality assessments included contrast sensitivity and higher-order aberrations (HOAs).

[RESULTS] Six patients (mean age 56.1 ± 7.2 years) completed the study. Mean OSDI scores significantly decreased from 48.6 ± 8.4 to 28 ± 2.1. TBUT improved in both eyes (right, 3.3 ± 1.0 to 5.6 ± 1.2 seconds; left, 3.6 ± 1.0 to 6.1 ± 1.6 seconds). Schirmer test I values increased (right, 4.1 ± 0.7 to 7.8 ± 0.7 mm; left, 4.0 ± 0.6 to 7.6 ± 0.5 mm). Oxford staining scores decreased (right, 1.6 ± 0.5 to 0.67 ± 0.2; left, 1.3 ± 0.5 to 0.67 ± 0.2). Tear osmolarity also improved (right, 311.6 ± 6.1 to 299.1 ± 5.8 mOsm/L; left, 309 ± 7.6 to 298.3 ± 7 mOsm/L). HOAs were reduced in one eye. No significant change in contrast sensitivity or visual acuity was observed. No adverse events were reported.

[CONCLUSIONS] Autologous ASC transplantation into the lacrimal gland appears to be a safe and promising therapeutic option for aqueous-deficient DED in Sjögren syndrome, offering significant improvement in both objective measures and patient-reported symptoms over a 6-month period.