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Lab-Grown eye cells injected to reverse corneal blindness

NCT ID NCT06726174

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests whether injecting cultured corneal endothelial cells into the eye can repair damaged corneas and improve vision. Twelve adults with corneal swelling and poor eyesight received a single injection of donor cells grown in a lab. The goal is to see if the cells can restore a healthy cell layer, reduce swelling, and improve sight.

What this could mean

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

Active substance
cultured corneal endothelial cells
What this could lead to
If successful, this could offer a new treatment to restore vision in people with corneal endothelial dysfunction, potentially reducing the need for corneal transplants.
What could go wrong
This is a very early Phase 1 trial with only 12 participants, so safety and effectiveness are not yet proven. The cells may not engraft properly or could cause inflammation or increased eye pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

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

Started

Apr 2025

Expected to finish

Dec 2028

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

20 to 90 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: \- Patient who's one eye or both eyes diagnosed with corneal endothelial cell dysfunction who met the following inclusion criteria were deemed eligible: 1. A BCVA of \< 0.5. 2. CECs could not be observed via specular microscopy or CEC density was \< 500 cells/mm2. 3. Corneal edema with a corneal thickness \> 650 μm. 4. Patient age at the time of obtaining written consent was between 20 and 90 years. 5. Written informed consent could be obtained. If both eyes meet the criteria of a. to c., the treatment eye in this trial will be the one with more sever vision impairment which caused by cornea endothelial cell dysfunction. Exclusion Criteria: \- Patients who met the following criteria parameters were deemed ineligible and were excluded from the study. 1. Patients with corneal infection (i.e., fungus, bacteria, virus. Etc.). 2. The treatment eye had been cataract surgery, pupilloplasty, or the vision or complication is not stabilized post-operation within one month before transplantation. 3. The treatment eye had received corneal transplantation, other eye surgeries, retinal laser, any kind of invasive eye treatment or drug injection within three months. 4. Pregnant patients (the urine or blood pregnancy test of woman of childbearing potential\* is positive) or patients who had recently given birth and were nursing the newborn child. \*:A woman of childbearing potential (WOCBP) is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable, or mechanical contraception; women who are single; women whose husbands have been vasectomized or whose husbands have received or are utilizing mechanical contraceptive devices. 5. Patients with a hemorrhagic disease (In the patients who is taking Warfarin, the INR is over 3.0.). 6. Patients who were judged by the attending physicians to be incapable of understanding the procedure or of providing sufficient corporation due to mental retardation or mental disorder. 7. Glaucoma patients with poor IOP control (Patients with maximum dosage of glaucoma medicines (Prostaglandin analogue, beta-blocker, alpha2 agonist, and carbonic anhydrase inhibitor) or after surgery, the IOP cannot be controlled under 25 mmHg.). 8. Patients with acute eye infection or inflammation (i.e., bacterial or fungal infection, acute uveitis.) 9. Diabetic patients with a poor blood-sugar control (Patients with HbA1c \> 10% within the past three months.). 10. Patients who were hypersensitive to steroids. 11. Patients with systemic autoimmune disease (i.e., systemic lupus erythematosus, Behcet's disease, etc.) 12. Patients strongly suspected to have a severe visual disorder due to concomitant other factors. 13. Patients who had already received this therapy. 14. Patients who had used or were planning to use an anti-cancer drug. 15. Patients with a past history of heart disease (i.e., myocardial infarction, heart failure, severe arrhythmia, etc.) or a cerebral vascular disorder. 16. Patients for whom it has been determined by the principal investigator or other co-investigators that there will be complications with the patient participating in the study for other reasons. 17. Patients who are allergic to the drug or ingredients used in this trial.

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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.

Contacts and locations

Locations

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan