A Single-Center Clinical Study to Evaluate the Efficacy and Safety of Autologous Urine-Derived Ep… (NCT07435142) | Clinical Trial Compass
RecruitingNot Applicable
A Single-Center Clinical Study to Evaluate the Efficacy and Safety of Autologous Urine-Derived Epithelial Cells in the Treatment of Corneal Endothelial Cell Dysfunction
China3 participantsStarted 2026-02-21
Plain-language summary
Corneal endothelial cell dysfunction is usually a corneal disease caused by damage or loss of corneal endothelial cells. It is characterized by corneal edema, opacity, and subepithelial bullae, leading to pain, blurred vision, or even blindness. Conventional treatments usually involve allogeneic corneal transplantation or corneal endothelial transplantation. Anterior chamber cell transplantation is a breakthrough treatment for corneal endothelial diseases developed in recent years. Autologous urine-derived epithelial cells greatly reduce the risk of immune rejection and the use of anti-rejection drugs, avoiding reliance on and waiting for corneal donors.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients diagnosed with corneal endothelial cell dysfunction, including those with a history of at least one penetrating keratoplasty.
. Patients aged 18 years or older and 85 years or younger at the time of informed consent acquisition (regardless of gender).
. Patients with central corneal endothelial cell density below 500-800 cells/mm² or unmeasurable, as detected by corneal endothelial microscopy or confocal microscopy.
. Patients who can voluntarily participate in the study and provide written informed consent.
Exclusion criteria
. Patients with unexplained keratoconjunctival diseases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change in corneal endothelial cell density (cells/mm²) from baseline to 6 months postoperatively, as measured by in vivo confocal microscopy
. Patients with active corneal infections or systemic infections (e.g., positive for bacteria, fungi, HBV, HCV, or other viruses).
. Patients with an intraocular pressure (IOP) of ≥30 mmHg (excluding those whose IOP can be controlled below 21 mmHg with glaucoma medications).
. Patients with neovascularization observed in the angle of the anterior chamber or who have undergone treatment for neovascular glaucoma.
. Patients with a history of allergies to drugs prescribed during the perioperative period and postoperative observation period \[anesthetics (lidocaine injection), antibiotics (ofloxacin eye drops or ointment), steroid preparations (0.1% fluorometholone eye drops, tobramycin and dexamethasone eye drops or ointment, prednisolone acetate eye drops or ointment), glaucoma medications (prostaglandin preparations, β-blockers, carbonic anhydrase inhibitors, linezolid eye drops), etc.\].
. Patients planning to undergo intraocular surgery during this clinical study.
. Diabetic patients with poor blood glucose control (HbA1C ≥8.5%).
. Patients with a history of cancer or/and with systemic autoimmune disease.