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

NCT07782138 | Not Yet Recruiting

• 1 other identifier: SDSYKYY202606-1
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cornea Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  48 weeks after NK-cell transplantation

Secondary Outcomes (3)

• Change of best-corrected visual acuity (BCVA) from baseline at week 48

  48 weeks after NK-cell transplantation

• Change in corneal endothelial cell density from baseline at 48 weeks after NK-cell transplantation

  48 weeks after NK-cell transplantation

• Incidence of adverse events throughout the 48-week observation period

  From NK-cell transplantation to the end of 48-week follow-up

Study Arms (1)

Allogeneic NK-Cell Transplantation Group

EXPERIMENTAL

Patients with Mooren's ulcer receive allogeneic NK-cell transplantation by subconjunctival injection. Post-treatment follow-up lasts for 48 weeks to assess efficacy and safety of this cell-based therapy.

Biological: Allogeneic natural killer (NK)-cell transplantation

Interventions

Allogeneic natural killer (NK)-cell transplantation BIOLOGICAL

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.

Allogeneic NK-Cell Transplantation Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• There are obvious symptoms such as eye pain, photophobia, tearing, and a foreign-body sensation, and conventional conservative medical treatments have shown poor efficacy.
• 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.
• Patients aged 18 or older and under 85 who consent to the acquisition (gender unrestricted).
• Patients who can provide written consent to voluntarily participate in the study from themselves.

You may not qualify if:

• Those who do not meet any of the above selection criteria.
• Patients who have participated in other clinical trials or clinical studies within the 3 months prior to consent to enrollment.
• Other patients who are deemed unsuitable for this clinical study due to comorbidities or other factors.

Sponsors & Collaborators

• Suxia Li: lead

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Suxia Li

CONTACT

+86 158 5410 7085; lsuxiasusu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 24, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF