An interventional study of Allogeneic natural killer (NK)-cell transplantation in Cornea Disease, sponsored by Suxia Li. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Suxia Li · Not applicable, Interventional, and Treatment
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.
219 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.
This study's planned enrollment of 6 is below the median of 40 across 132 interventional studies indexed under Corneal Diseases.
Browse Corneal Diseases studies →Suxia Li is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Subjects must meet all of the following inclusion criteria to participate in the study:
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria shall not be allowed to participate in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Start is estimated for Nov 2026; primary completion for Nov 2027, 11 months later.
Of 37 non-industry interventional studies with no phase under Corneal Diseases, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 54. This study's planned 11 months is below that.
Counting every sponsor, half of 43 studies reached it within 22 months; a quarter within 5 and three quarters within 45.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Nov 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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