Cornea Disease
Conditions
Brief summary
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.
Interventions
BIOLOGICALAllogeneic natural killer (NK)-cell transplantation
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.
Sponsors
Suxia Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to participate in the study: 1. Clinically confirmed as a corneal ulcer with undermining characteristics, meeting the clinical diagnostic criteria for undermining corneal ulcers (infiltration and ulceration appearing at the peripheral cornea, or showing progressive development accompanied by ciliary injection; other corneal lesions have been ruled out). 2. The ulcerative lesion covers an area no greater than half the circumference of the cornea, with stromal infiltration depth not exceeding 1/3 to 2/3 of the corneal thickness; no severe complications such as corneal perforation or endophthalmitis have occurred. 3. There are obvious symptoms such as eye pain, photophobia, tearing, and a foreign-body sensation, and conventional conservative medical treatments have shown poor efficacy. 4. The intraocular pressure of the affected eye is within the normal range (10-21 mmHg), and there are no associated ocular conditions such as severe blepharitis or dacryocystitis. The contralateral eye has no history of corneal ulceration due to keratitis or active lesions. 5. Patients aged 18 or older and under 85 who consent to the acquisition (gender unrestricted). 6. Patients who can provide written consent to voluntarily participate in the study from themselves.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in central corneal thickness compared with baseline at 48 weeks after NK-cell transplantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of best-corrected visual acuity (BCVA) from baseline at week 48 | 48 weeks after NK-cell transplantation | 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. |
| Change in corneal endothelial cell density from baseline at 48 weeks after NK-cell transplantation | 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. |
| Incidence of adverse events throughout the 48-week observation period | From NK-cell transplantation to the end of 48-week follow-up | 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. |
Contacts
CONTACTSuxia Li
Outcome results
None listed