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

Обзор

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.

Вмешательства

• Биопрепарат Autologous urinary-derived epithelial cell injection
  Cell therapy

Первичные конечные точки

• Mean change in corneal endothelial cell density (cells/mm²) from baseline to 6 months postoperatively, as measured by in vivo confocal microscopy [Срок оценки: 6 months postoperatively]

Вторичные конечные точки (3)

• Mean change in best-corrected visual acuity (logMAR) from baseline to 6 months postoperatively, as measured by Snellen chart [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 6 months postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shandong Eye Hospital — Цзинань

Идентификаторы

NCT: NCT07435142 · SDYEC (Meeting) R20250501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗