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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSuxia Li

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Autologous urinary-derived epithelial cell injection

Treatment groups

3 Participants
are divided into 1 treatment group

Locations

1
Shandong Eye Hospital JinanShandong, China

Sponsors and collaborators

Suxia Li

Lead sponsor

Shandong Eye Hospital

Sponsor institution