jRCTa031210199进行中（未招募）不适用
Exploratory clinical study to examine safety and efficacy of iPS cell-derived corneal endothelial cell substitutes for bullous keratopathy (CLS001)
未提供0 个研究点目标入组 3 人开始时间: 2022年7月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3
- 主要终点
- safety endpoint (systemic)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 45age old over 至 85age old under（—）
- 性别
- All
入选标准
- •A diagnosis of bullous keratopathy after corneal transplantation, including at least one previous penetrating keratoplasty.
- •Forty five years of age or older and under 85 years of age at the time of consent acquisition (male or female)
- •A central corneal endothelial cell density of less than 500 cells/mm^2 measured by specular microscope or confocal microscope, or undetactable.
- •Voluntary written consent to participate in the study.
排除标准
- •Patients with undiagnosed keratoconjunctival disease.
- •Central corneal thickness of 1200 micro meter or blood vessel invasion in the stroma of cornea.
- •i) Active corneal infection OR ii) Active systemic infections (bacteria, fungi, positive in viral test such as hepatitis B virus, hepatitis C virus, etc.).
- •IOP >= 30 mmHg or even with glaucoma drugs administration IOP >= 21 mmHg
- •Diabetes that it difficult to control(HbA1C 8.0% or higher).(This can be omitted in the primary verification of eligibility.)
- •Neovascularization in the iridocorneal angle or after neovascular glaucoma treatment.
- •Medical history of hypersensitivity to anesthetic(xylocaine injection solution), antibiotics(levofloxacin ophthalmic solution),steroids(sanbetason ophthalmic and otorhinologic solution 0.1%, flumetholon ophthalmic suspension 0.1%),glaucoma treatment(prostaglandin analog, beta inhibitor,azopt otorhinologic solution, glanatec otorhinologic solution and so on),used during perioperative and postoperative observation.
- •Scheduled to undergo internal eye surgery during the study.
- •Medical history of cancer
- •Presence of significant hepatic failure (with either AST or ALT higher than 100 IU/L).(This can be omitted in the primary verification of eligibility.)
- •Presence of renal failure requiring dialysis(serum creatinine level 1.5 mg/dl or higher).(This can be omitted in the primary verification of eligibility.)
- •Systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher, even with antihypertensive drug.
- •Not consent to contraception or hopes his partner's pregnancy during the study.
- •Cannot endure ophthalmic surgery under local anesthesia (Extreme claustrophobia, etc.).
- •Participation in other clinical trials one month prior to when informed consent is obtained
- •Other cases where the principal investigator or sub investigator decides the subject is unsuitable for the study.
- •1 : The following items refer to transplanted eyes. 1)-4), 6)and 8).
- •2 : These tests examine the patient's blood type and HLA gene type during screening. The results are not used to determine exclusion criteria, regardless of whether his or her blood type or HLA type matches that of the iPS cell donor.
结局指标
主要结局
safety endpoint (systemic)
All adverse events, including systemic symptoms
safety endpoint (ophthalmologic)
[The following adverse events caused by iPS cell-derived corneal endothelium substitute cells] - Unintended cell proliferation - Increased intraocular pressure - Rejection reaction [The following adverse events resulting from transplant surgery and procedures] - Infectious disease - Cataract progression - Expulsive Hemorrhage
次要结局
未报告次要终点
研究者
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