Can immune cells heal a rare eye ulcer?

NCT ID NCT07782138

Disease control Sponsor: Suxia Li Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether injecting natural killer (NK) cells into the eye can help people with refractory Mooren's ulcer, a painful and recurring corneal condition. Six participants will receive the cell injection and be followed for 48 weeks to see if it improves corneal thickness and vision. The goal is to find a safer, minimally invasive treatment that reduces relapse without the risk of graft-versus-host disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Allogeneic natural killer (NK) cell transplantation via subconjunctival injection
What this could lead to
If successful, this could offer a new, minimally invasive treatment option for people with hard-to-treat Mooren's ulcer, potentially reducing relapse and improving vision.
What could go wrong
This is a very small early-stage study (6 participants) with no control group, so results may not generalize. Risks include injection-related complications and uncertain long-term efficacy.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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