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

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.
• 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.
• Patients with severe liver dysfunction (AST>100 IU/L or ALT>100 IU/L).
• Patients with severe renal dysfunction requiring dialysis (serum creatinine ≥1.5 mg/dl).
• Patients with a systolic blood pressure of ≥180 mmHg or diastolic blood pressure of ≥110 mmHg despite antihypertensive treatment.
• Pregnant women, women possibly pregnant, or women planning pregnancy during this clinical study period.
• Patients unable to tolerate ophthalmic surgery under local anesthesia (e.g., severe claustrophobia).
• Patients who participated in other clinical trials or studies within 3 month prior to consent acquisition.
• Patients deemed unsuitable for this clinical study due to comorbidities, etc.