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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cornea Disease
• Intervention / Treatment: Biological: Autologous urinary-derived epithelial cell injection

• Study Type: Interventional
• Enrollment (Estimated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xia Su Li; Phone Number: +86 158 5410 7085; Email: lsuxiasusu@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Shandong Eye Hospital
      • Contact: Suxia Li; Phone Number: +86 158 5410 7085; Email: lsuxiasusu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Single-Center Clinical Study; Autologous Urine-Derived Epithelial Cells in the Treatment of Corneal Endothelial Cell Dysfunction	Biological: Autologous urinary-derived epithelial cell injection; Cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in corneal endothelial cell density (cells/mm²) from baseline to 6 months postoperatively, as measured by in vivo confocal microscopy	Corneal endothelial cell density (ECD) will be measured using in vivo confocal microscopy at baseline (preoperatively) and 6 months postoperatively. The primary endpoint is the mean change in ECD from baseline to 6 months postoperatively. ECD will be reported as cells/mm², with standard deviation (SD) and 95% confidence interval (CI). Only eyes with valid ECD measurements at both time points will be included in the primary analysis	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in best-corrected visual acuity (logMAR) from baseline to 6 months postoperatively, as measured by Snellen chart	Mean change in best-corrected visual acuity (logMAR) from baseline to 6 months postoperatively, as measured by Snellen chart	6 months postoperatively
Proportion of eyes with improved corneal transparency (4-point scale: 0 = clear, 1 = mild haze, 2 = moderate haze, 3 = severe haze) at 6 months postoperatively, as graded by slit-lamp biomicroscopy	Corneal transparency will be graded by slit-lamp biomicroscopy at baseline and 6 months postoperatively using a 4-point scale (0 = clear, 1 = mild haze, 2 = moderate haze, 3 = severe haze). The proportion of eyes with a ≥1-grade improvement in transparency will be reported	6 months postoperatively
Mean change in central corneal thickness (μm) from baseline to 6 months postoperatively, as measured by anterior segment optical coherence tomography (AS-OCT)	Central corneal thickness (CCT) will be measured using anterior segment optical coherence tomography (AS-OCT) at baseline and 6 months postoperatively. The mean change in CCT (μm) from baseline to 6 months will be reported, with standard deviation and 95% confidence interval.	6 months postoperatively

Collaborators and Investigators

• Sponsor: Suxia Li

Study record dates

Study Major Dates

• Study Start (Estimated): February 21, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases
• Other Study ID Numbers: SDYEC (Meeting) R20250501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No