Feasibility and Safety of Adult Human Bone Marrow-Derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change from baseline in laser flare and cell measurements
研究概览
简要总结
The purpose of this study is to determine the feasibility and safety of adult human bone marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis pigmentosa.
详细描述
Retinitis pigmentosa (RP) is an inherited disorder of the photoreceptor cells in the retina. Patients may lose vision since they were young or later in life. Currently, there are more than 60 genes identified as the cause of this condition, one of which, RPE65, has been studied in several gene therapy trials for Leber congenital amaurosis with promising results. Another treatment approach for RP is stem cell therapy. Studies in animal models of RP have shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay degenerative changes of photoreceptor cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retinitis pigmentosa patients diagnosed by ophthalmologists
- •Age 18-65 years old
- •Central visual field less than or equal to 20 degrees
- •Best corrected visual acuity less than 6/120 by Snellen visual acuity chart
- •Electroretinogram nonrecordable or the amplitudes were less than 25% of normal
排除标准
- •Other eye conditions that could mask the interpretation of the results
- •Unable to return for follow up
- •Underlying diseases including asthma, heart failure, myocardial infarction, liver failure, renal failure
- •Pregnant and lactating women
结局指标
主要结局
Change from baseline in laser flare and cell measurements
时间窗: up to 12 months
次要结局
- Change from baseline in visual function tests(up to 12 months)
研究者
La-ongsri Atchaneeyasakul
Professor
Mahidol University