Phase 1 Study of the Feasibility and Safety of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Eyes With Vision Loss From Retinitis Pigmentosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Safety of intravitreal injection of autologous CD34+ cells
研究概览
简要总结
In this Phase 1 open-labeled prospective study, one eye of each participant with vision loss from retinitis pigmentosa will be administered intravitreal injection of autologous CD34+ stem cells harvested from bone marrow. Each participant will be examined serially for 6 months after study injection to determine safety and feasibility of this intervention.
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 —（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 at Presentation of 20/100 to Counting Fingers or constriction of peripheral visual field 360 degrees to <10 degrees by perimetry if BCVA is better than 20/100, duration of vision loss > 3 months
- •Vision loss due to retinitis pigmentosa
- •The study eye has the worse visual acuity or peripheral constriction.
- •Able and willing to sign consent
- •Able to keep follow-up appointments for at least 6 months
排除标准
- •Other concurrent optic nerve or retinal disease in study eye affecting vision
- •History of active retinal or choroidal neovascularization or macular edema in study eye requiring on-going intravitreal or periocular therapy in study eye
- •Active eye or systemic infection
- •Significant media opacity in the study eye precluding view of the fundus for examination, photography or optical coherence tomography (OCT)
- •Other cause for vision loss in the study eye
- •History of coagulopathy or other hematologic abnormality
- •Use of coumadin within 3 days of enrollment
- •Concurrent immunosuppressive therapy
- •History of allergy to fluorescein dye
研究组 & 干预措施
Intravitreal autologous CD34+ cells
Intravitreal injection of autologous CD34+ cells harvested from bone marrow under GMP conditions
干预措施: Intravitreal autologous CD34+ cells (Biological)
结局指标
主要结局
Safety of intravitreal injection of autologous CD34+ cells
时间窗: 6 months
Number and severity of Ocular and systemic adverse events
Feasibility of intravitreal injection of autologous CD34+ cells
时间窗: Baseline
Number of CD34+ cells harvested for intravitreal injection
次要结局
- Visual Field(1 month)
- National Eye Institute Vision Questionnaire(1 month)
- Best corrected visual acuity(1 month)
- Microperimetry(1 month)
- Electroretinography(1 month)
研究者
Susanna Park, MD, PhD
Professor
University of California, Davis