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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Mean change in corneal endothelial cell density (cells/mm²) from baseline to 6 months postoperatively, as measured by in vivo confocal microscopy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean change in corneal endothelial cell density (cells/mm²) from baseline to 6 months postoperatively, as measured by in vivo confocal microscopy
时间窗: 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
次要结局
- 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(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)(6 months postoperatively)
研究者
Suxia Li
Sponsor-Investigator
Shandong Eye Hospital