Cornea DiseaseNCT07782138
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
A study testing Allogeneic natural killer (NK)-cell transplantation in people with Cornea Disease, run by Suxia Li.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cornea Disease
- What is being tested?
- Allogeneic natural killer (NK)-cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to participate in the study:
- 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.
Who cannot join
- Subjects meeting any of the following exclusion criteria shall not be allowed to participate in the study:
- Those who do not meet any of the above selection criteria.
- 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.).
- 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%).
- 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.
- 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.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Allogeneic natural killer (NK)-cell transplantation
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic natural killer (NK)-cell transplantationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Allogeneic natural killer (NK)-cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks after NK-cell transplantation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From NK-cell transplantation to the end of 48-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cornea DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suxia Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suxia Li, Shandong Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782138
- Sponsor's protocol ID
- SDSYKYY202606-1
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
- ClinicalTrials.gov ID
- NCT07782138
- Acronym / sponsor ID
- SDSYKYY202606-1
- Conditions
- Cornea Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Suxia LiUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic NK-Cell Transplantation Group | Experimental | Biological: Allogeneic natural killer (NK)-cell transplantationPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- Subjects meeting any of the following exclusion criteria shall not be allowed to participate in the study:
- Those who do not meet any of the above selection criteria.
- 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.).
- 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%).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic natural killer (NK)-cell transplantationInvestigational 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. | Biological | Allogeneic NK-Cell Transplantation Group |
Primary outcome
Change in central corneal thickness compared with baseline at 48 weeks after NK-cell transplantation
Time frame: 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.
3 secondary outcomes
Change of best-corrected visual acuity (BCVA) from baseline at week 48
Time frame: 48 weeks after NK-cell transplantation
Change in corneal endothelial cell density from baseline at 48 weeks after NK-cell transplantation
Time frame: 48 weeks after NK-cell transplantation
Incidence of adverse events throughout the 48-week observation period
Time frame: From NK-cell transplantation to the end of 48-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic natural killer (NK)-cell transplantation in people with Cornea Disease, run by Suxia Li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suxia Li (+86 158 5410 7085, lsuxiasusu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in central corneal thickness compared with baseline at 48 weeks after NK-cell transplantation (time frame: 48 weeks after NK-cell transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.