NCT01674829终止1 期
A Phase I/IIa, Open-Label, Single-Center, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (MA09-hRPE) Cells in Patients With Advanced Dry Age-related Macular Degeneration(AMD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety of hESC derived RPE cells
研究概览
简要总结
To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry AMD To evaluate the safety of the surgical procedures when used to implant MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of MA09-hRPE cellular therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female over 55 years of age. Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment
- •Clinical findings consistent with advanced dry AMD
- •GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
- •No evidence of current or prior choroidal neovascularization in the treated eye
- •The visual acuity (BCVA) of the eye to receive the transplant found to be eligible for trial based on study protocol
- •Electrophysiological findings consistent with advanced dry AMD.
- •Medically suitable to undergo vitrectomy and subretinal injection.
- •Medically suitable for general anesthesia or waking sedation, if needed.
- •Medically suitable for transplantation of an embryonic stem cell line
排除标准
- •Presence of active or inactive CNV in the eye to be treated.
- •Presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy or other retinal vascular or degenerative disease other than ARMD.
- •History of optic neuropathy.
- •Macular atrophy due to causes other than AMD.
- •Presence of glaucomatous optic neuropathy in the study eye, uncontrolled IOP, or use of two or more agents to control IOP (acetazolamide, beta blocker, alpha-1-agonist, prostaglandins, anhydrous carbonic inhibitors)
- •Cataract of sufficient severity likely to necessitate surgical extraction within 1 year.
- •History of retinal detachment repair in the study eye.
- •History of myocardial infarction in previous 12 months.
- •History of diabetes mellitus.
- •History of cognitive impairments or dementia which may impact the patients ability participate in the informed consent process and to appropriately complete evaluations.
- •Any immunodeficiency.
- •Any abnormalities in laboratory test result.
- •Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
- •Current participation in any other clinical trial.
- •Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
- •Any other sight-threatening ocular disease.
- •Ocular lens removal within previous 3 months.
- •Ocular surgery in the study eye in the previous 3 months
- •If female, pregnancy or lactation.
- •Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
结局指标
主要结局
Safety of hESC derived RPE cells
时间窗: 12 months
The transplantation of hESC-derived RPE cells MA09-hRPE will be considered safe in the absence of: 1. Any grade 2 (NCI grading system) or greater adverse event related to the cell product 2. Any evidence that the cells are contaminated with an infectious agent 3. Any evidence that the cells show tumorigenic potential
次要结局
- exploratory evaluations for potential efficacy endpoints(12months)
研究者
研究点 (2)
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