A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence and severity of ocular adverse events
研究概览
简要总结
This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.
详细描述
In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years of age
- •visual acuity 20/100 to CF
- •duration of vision loss > 3 months
- •vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy
- •the study eye has the worse visual acuity
- •no active eye or systemic disease
- •no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months
- •no significant media opacity
- •no coagulopathy or other hematologic abnormality
- •no concurrent immunosuppressive therapy
- •able to keep follow-up for 6 months
排除标准
- •allergy to fluorescein dye
- •other concurrent retinal or optic nerve disease affecting vision
研究组 & 干预措施
Stem cell treated
干预措施: CD34+ bone marrow stem cells intravitreal (Drug)
结局指标
主要结局
Incidence and severity of ocular adverse events
时间窗: 1 day to 6 months
As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.
次要结局
- The number of stem cells isolated and injected into the study eye(1 day)