Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
Treatment of age-related macular degeneration using retinal stem and progenitor cells
详细描述
The aim of the project is to develop a biomedical cell product based on retinal pigment epithelium cells for highly effective treatment age-related macular degeneration; to conduct the clinical trials of the biomedical cell product in the treatment of age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of age-related macular degeneration
- •The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- •Written informed consent
排除标准
- •The presence of any malignant tumor within the last 5 years
- •Acute or chronic diseases in the stage of decompensation
- •Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
- •Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
- •Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
- •Patients are unable or unwilling to give written informed consent and / or follow research procedures
- •Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
研究组 & 干预措施
Patients with age-related macular degeneration receiving standard treatment and retinal stem cells
Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells
干预措施: Cultured retinal stem and progenitor cells (Biological)
Patients with age-related macular degeneration receiving standard treatment and retinal stem cells
Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells
干预措施: Standard treatment according to the clinical protocols (Other)
Patients with age-related macular degeneration receiving standard treatment
Patients with age-related macular degeneration receiving standard treatment
干预措施: Standard treatment according to the clinical protocols (Other)
结局指标
主要结局
Visual acuity
时间窗: 1 year
Determination of visual acuity after the therapy
Adverse effects associated with the therapy
时间窗: 1 year
Determination of adverse effects associated with the therapy
Visual acuity
时间窗: 1 month
Determination of visual acuity after the therapy
Adverse effects associated with the therapy
时间窗: 1 month
Determination of adverse effects associated with the therapy
次要结局
未报告次要终点