Autologous urine-derived epithelial cells to treat corneal endothelial cell dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, single-center study evaluates the safety and potential benefit of autologous urine-derived epithelial cell injections for corneal endothelial cell dysfunction. Eligible adults with reduced central corneal endothelial cell density may receive injections in the eye, aiming to reduce edema and improve transparency while avoiding donor tissue and immune rejection. The approach leverages a patient’s own cells to minimize immune-related complications compared with traditional allogeneic transplants. The study criteria include prior corneal surgery history and specific endothelial cell density thresholds, with safety monitoring for ocular and systemic infections and intraocular pressure. Enrollment is centered at Shandong Eye Hospital under an identified lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shandong Eye Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: xia Su Li
• Email: lsuxiasusu@163.com
• Phone: +86 158 5410 7085

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.