Could urine cells heal blindness? tiny trial begins

NCT ID NCT07435142

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests whether a patient's own urine-derived cells can be injected into the eye to repair damaged corneal cells. The trial enrolls just 3 people with corneal endothelial dysfunction, a condition that can cause pain and vision loss. The goal is to see if the cells improve corneal cell density and vision, potentially reducing the need for donor transplants and anti-rejection drugs.

What this could mean

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

Active substance
autologous urine-derived epithelial cells
What this could lead to
If it works, this could offer a new way to treat corneal damage using a patient's own cells, avoiding donor transplants and reducing anti-rejection drug use.
What could go wrong
This is a very early, tiny trial (only 3 people) with no phase, so results may not apply widely. The approach is experimental and may not improve vision or cell density.

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

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 3 people

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

Started

Feb 2026

Expected to finish

Nov 2026

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: 1. Patients diagnosed with corneal endothelial cell dysfunction, including those with a history of at least one penetrating keratoplasty. 2. Patients aged 18 years or older and 85 years or younger at the time of informed consent acquisition (regardless of gender). 3. Patients with central corneal endothelial cell density below 500-800 cells/mm² or unmeasurable, as detected by corneal endothelial microscopy or confocal microscopy. 4. Patients who can voluntarily participate in the study and provide written informed consent. Exclusion Criteria: 1. Patients with unexplained keratoconjunctival diseases. 2. Patients with active corneal infections or systemic infections (e.g., positive for bacteria, fungi, HBV, HCV, or other viruses). 3. Patients with an intraocular pressure (IOP) of ≥30 mmHg (excluding those whose IOP can be controlled below 21 mmHg with glaucoma medications). 4. Patients with neovascularization observed in the angle of the anterior chamber or who have undergone treatment for neovascular glaucoma. 5. Patients with a history of allergies to drugs prescribed during the perioperative period and postoperative observation period \[anesthetics (lidocaine injection), antibiotics (ofloxacin eye drops or ointment), steroid preparations (0.1% fluorometholone eye drops, tobramycin and dexamethasone eye drops or ointment, prednisolone acetate eye drops or ointment), glaucoma medications (prostaglandin preparations, β-blockers, carbonic anhydrase inhibitors, linezolid eye drops), etc.\]. 6. Patients planning to undergo intraocular surgery during this clinical study. 7. Diabetic patients with poor blood glucose control (HbA1C ≥8.5%). 8. Patients with a history of cancer or/and with systemic autoimmune disease. 9. Patients with severe liver dysfunction (AST\>100 IU/L or ALT\>100 IU/L). 10. Patients with severe renal dysfunction requiring dialysis (serum creatinine ≥1.5 mg/dl). 11. Patients with a systolic blood pressure of ≥180 mmHg or diastolic blood pressure of ≥110 mmHg despite antihypertensive treatment. 12. Pregnant women, women possibly pregnant, or women planning pregnancy during this clinical study period. 13. Patients unable to tolerate ophthalmic surgery under local anesthesia (e.g., severe claustrophobia). 14. Patients who participated in other clinical trials or studies within 3 month prior to consent acquisition. 15. Patients deemed unsuitable for this clinical study due to comorbidities, etc.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shandong Eye Hospital

    RECRUITING

    Jinan, Shandong, China

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