A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer

A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer

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.

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 exclusion criteria shall not be allowed to participate in the study:

1. Those who do not meet any of the above selection criteria.
2. Exclusion criteria related to corneal lesions: The corneal ulcer has already developed severe complications such as perforation, endophthalmitis, or corneal hydrops; the ulcer area exceeds half of the corneal circumference, or the depth of corneal stromal infiltration exceeds two-thirds of the corneal thickness; or the patient has concurrent other corneal diseases (such as infectious keratitis, keratoconus, corneal dystrophy, etc.).
3. Exclusion of systemic diseases: Individuals with severe cardiovascular and cerebrovascular diseases, hepatic or renal dysfunction (hepatic function-ALT/AST exceeding 1.5 times the upper limit of normal; renal function-creatinine exceeding 1.2 times the upper limit of normal), hematopoietic dysfunction, or uncontrolled autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.); individuals with active infections, malignant tumors, or a history of surgery within the past 3 months; and diabetic patients with poor glycemic control (HbA1C above 8.5%).
4. Exclusion of special populations: pregnant women and breastfeeding women; individuals (both men and women) who have plans to conceive and are not using effective contraception; individuals with alcohol dependence or substance abuse.
5. Other exclusions: Subjects unable to comply with clinical trial follow-up and examinations; subjects with other factors that may affect the assessment of trial results (such as a history of ocular trauma, congenital ocular malformations, etc.); subjects deemed by the investigator as unsuitable for inclusion in the trial.
6. Patients who have participated in other clinical trials or clinical studies within the 3 months prior to consent to enrollment.
7. Other patients who are deemed unsuitable for this clinical study due to comorbidities or other factors.