NCT03566147Unknown早期 1 期
Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation
Eyecure Therapeutics Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- best-corrected visual acuity (BCVA)
研究概览
简要总结
Early Phase I Study of the Safety and Preliminary Efficacy of Human primary Retinal Pigment Epithelial (HuRPE) Cells Subretinal Transplantation in Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) Patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RP or LCA;
- •Experimental eye with best-corrected visual acuity (BCVA) of no more than 35 letters or visual field of less than 10 degree;
- •Patient understand and sign the consent form.
排除标准
- •Blood routine examination is abnormal (hemoglobin<10gm/dL; blood platelet count<100k/mm³; neutrophil count<1000/mm³)
- •Blood biochemistry is abnormal (ALT／AST>1.5; creatinine>1.3mg/dL)
- •Experimental eye has optic nerve atrophy caused by glaucoma
- •Experimental eye has retinal detachment, or has received retinal detachment surgery.
- •Patients with uveitis and other endophthalmitis
- •Patients with other ocular disease affecting vision.
- •Patients have participated in clinical study of ocular or systemic drug use in recent 6 months.
- •Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma).
- •Patients with medical history of myocardial infarction
- •Patient with diabetes
- •Patient with Parkinson disease or Alzheimer's disease
- •Patients are under the treatment of immunosuppressive agent (except intermittent, low-dose corticosteroid treatment).
- •Patients with other medical conditions that restricts the compliance and safety of patients, or affects experimental results.
研究组 & 干预措施
low dose group
Experimental
300,000 HuRPE cells
干预措施: Human primary Retinal Pigment Epithelial (HuRPE) cells (Biological)
middle dose group
Experimental
500,000 HuRPE cells
干预措施: Human primary Retinal Pigment Epithelial (HuRPE) cells (Biological)
high dose group
Experimental
1,000,000 HuRPE cells
干预措施: Human primary Retinal Pigment Epithelial (HuRPE) cells (Biological)
结局指标
主要结局
best-corrected visual acuity (BCVA)
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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