NCT06726174Enrolling By Invitation1 期
Phase I Clinical Trial of Corneal Endothelial Cell Therapy for Corneal Endothelial Cell Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- CEC density
研究概览
简要总结
Culture endothelial cells harvested from donor corneal tissue to treat corneal endothelial cell dysfunction. After ex vivo cultivation, the cells will be injected into anterior chamber and endothelial cells will settle down and adhere to the denuded Descemet's membrane. Eventually, they will reconstitute functional corneal endothelium to subside the corneal edema and improve the visual acuity.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who's one eye or both eyes diagnosed with corneal endothelial cell dysfunction who met the following inclusion criteria were deemed eligible:
- •A BCVA of < 0.
- •CECs could not be observed via specular microscopy or CEC density was < 500 cells/mm
- •Corneal edema with a corneal thickness > 650 μm.
- •Patient age at the time of obtaining written consent was between 20 and 90 years.
- •Written informed consent could be obtained. If both eyes meet the criteria of a. to c., the treatment eye in this trial will be the one with more sever vision impairment which caused by cornea endothelial cell dysfunction.
排除标准
- •- Patients who met the following criteria parameters were deemed ineligible and were excluded from the study.
- •Patients with corneal infection (i.e., fungus, bacteria, virus. Etc.).
- •The treatment eye had been cataract surgery, pupilloplasty, or the vision or complication is not stabilized post-operation within one month before transplantation.
- •The treatment eye had received corneal transplantation, other eye surgeries, retinal laser, any kind of invasive eye treatment or drug injection within three months.
- •Pregnant patients (the urine or blood pregnancy test of woman of childbearing potential* is positive) or patients who had recently given birth and were nursing the newborn child.
- •*：A woman of childbearing potential (WOCBP) is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable, or mechanical contraception; women who are single; women whose husbands have been vasectomized or whose husbands have received or are utilizing mechanical contraceptive devices.
- •Patients with a hemorrhagic disease (In the patients who is taking Warfarin, the INR is over 3.0.).
- •Patients who were judged by the attending physicians to be incapable of understanding the procedure or of providing sufficient corporation due to mental retardation or mental disorder.
- •Glaucoma patients with poor IOP control (Patients with maximum dosage of glaucoma medicines (Prostaglandin analogue, beta-blocker, alpha2 agonist, and carbonic anhydrase inhibitor) or after surgery, the IOP cannot be controlled under 25 mmHg.).
- •Patients with acute eye infection or inflammation (i.e., bacterial or fungal infection, acute uveitis.)
- •Diabetic patients with a poor blood-sugar control (Patients with HbA1c > 10% within the past three months.).
- •Patients who were hypersensitive to steroids.
- •Patients with systemic autoimmune disease (i.e., systemic lupus erythematosus, Behcet's disease, etc.)
- •Patients strongly suspected to have a severe visual disorder due to concomitant other factors.
- •Patients who had already received this therapy.
- •Patients who had used or were planning to use an anti-cancer drug.
- •Patients with a past history of heart disease (i.e., myocardial infarction, heart failure, severe arrhythmia, etc.) or a cerebral vascular disorder.
- •Patients for whom it has been determined by the principal investigator or other co-investigators that there will be complications with the patient participating in the study for other reasons.
- •Patients who are allergic to the drug or ingredients used in this trial.
研究组 & 干预措施
Cell
Experimental
干预措施: ECCEC (Drug)
结局指标
主要结局
CEC density
时间窗: 24-weeks
\> 500 cells/mm2
次要结局
- Corneal thickness(24-weeks)
研究者
研究点 (1)
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