NCT07782138|Not Yet Recruiting
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Sponsor study identifier
interventional
6
0 countries
N/A
Study Start
August 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2026
Actual (reported)August 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 24, 2026
Actual (reported)November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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First Submitted
July 29, 2026
First Posted
August 24, 2026
Study Start
August 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 1, 2027
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 24, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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