Given that the definitive pathogenesis of Mooren's ulcer has not been fully clarified and clinical relapse occurs frequently, natural killer (NK)-cells demonstrate unique therapeutic potential. Since NK cells do not express T-cell receptors (TCRs), they exert biological functions through a specific self-versus-non-self recognition pathway and hardly induce graft-versus-host disease (GVHD) after transplantation. Therefore, NK-cells serve as an ideal cellular therapeutic vehicle for such autoimmune diseases. This project targets refractory Mooren's ulcer by taking advantage of the distinctive immunological properties of NK-cells for disease intervention. Its core merits consist of eliminating the risk of GVHD and conferring immunomodulatory effects. From a clinical perspective, this study fills the research gap of cell-based therapies focused on the relapse mechanism of Mooren's ulcer and delivers a minimally-invasive and safe novel therapeutic option for intractable patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Investigational allogeneic NK-cells will be delivered via subconjunctival injection for patients with refractory Mooren's ulcer under strict sterile conditions. After cell transplantation, patients will receive routine topical ophthalmic medications and regular slit-lamp examinations. Participants are followed-up for 48-weeks to evaluate corneal recovery, visual changes and safety profiles of this cell-based intervention.
Change in central corneal thickness compared with baseline at 48 weeks after NK-cell transplantation
Central corneal thickness, measured in micrometers (μm), will be assessed in patients with refractory Mooren's ulcer before treatment and at the 48-week follow-up after subconjunctival injection of allogeneic NK-cells. The change in central corneal thickness from baseline to 48 weeks, expressed in μm, will be calculated to assess therapeutic efficacy.
Time frame: 48 weeks after NK-cell transplantation
Change of best-corrected visual acuity (BCVA) from baseline at week 48
Best-corrected visual acuity, measured as the number of correctly identified letters on a standardized ETDRS chart, will be assessed in patients with refractory Mooren's ulcer before treatment and at the 48-week follow-up after subconjunctival injection of allogeneic NK-cells. The change in best-corrected visual acuity from baseline, expressed as the number of ETDRS letters gained, will be calculated to evaluate the improvement in visual function following NK-cell intervention.
Time frame: 48 weeks after NK-cell transplantation
Change in corneal endothelial cell density from baseline at 48 weeks after NK-cell transplantation
Corneal endothelial cell density, measured in cells per square millimeter (cells/mm²), will be assessed in patients with refractory Mooren's ulcer before treatment and at the 48-week follow-up after subconjunctival injection of allogeneic NK-cells. The change in corneal endothelial cell density from baseline to 48 weeks, expressed in cells/mm², will be calculated to evaluate the effect of NK-cell transplantation on corneal endothelial function.
Time frame: 48 weeks after NK-cell transplantation
Incidence of adverse events throughout the 48-week observation period
Ocular local reactions, including conjunctival hyperemia, chemosis, anterior chamber inflammation, and corneal epithelial defects, as well as ocular infections, will be recorded and graded according to standardized grading scales (e.g., the Common Terminology Criteria for Adverse Events \[CTCAE\]) in patients with refractory Mooren's ulcer following subconjunctival injection of allogeneic NK-cells. The incidence and severity of ocular local reactions and infections will be summarized to evaluate the ocular safety of NK-cell transplantation.
Time frame: From NK-cell transplantation to the end of 48-week follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.