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

February 24, 2026 updated by: Suxia Li
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Shandong Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 6 months postoperatively
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 6 months postoperatively
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
Time Frame: 6 months postoperatively
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)
Time Frame: 6 months postoperatively
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suxia Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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