Intravitreal Injection of Human Bone Marrow Derived Mesenchymal Stem Cell in Patients With Dry Age-related Macular Degeneration(AMD)
试验速览
- 阶段
- 1 期
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- number of subjects with adverse events
研究概览
简要总结
The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral intravitreally transplantation of adult bone marrow stem cells in subjects with geographic atrophy secondary to age-related macular degeneration.
详细描述
This study is an open-label investigation of the safety and preliminary efficacy of unilateral intravitreal injection of autologous bone marrow stem cells in subjects with Geographic Atrophy secondary to Age-Related Macular Degeneration (AMD). Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals.
Human central nervous system -stem cells will be transplanted by a vitreoretinal surgeon. The transplantation will be conducted in the eye with the inferior best-corrected visual acuity (BCVA) (i.e., the Study Eye). Only the Study Eye will undergo transplantation. The adult bone marrow stem cells will be administered into the vitreous cavity through a standard surgical approach.
Moxifloxacin 300 mg(once per day ) will be administered orally to all subjects for a period of five days ( 2 days pre and post operatively) .
Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection .
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of age-related macular degeneration with geographic atrophy (GA)
- •Only patients with a specific degree and extent of GA will be eligible
- •Subjects with best-corrected visual acuity (BCVA) of less than or equal to 20/400 in the Study Eye
- •No prior or current choroidal neovascularization in either eye
- •Able to provide written informed consent prior to any study related procedures
- •Agree to comply in good faith with all conditions of the study and to attend all required study visits
排除标准
- •Prior vitreal or retinal surgery in the previous 6 months
- •Atrophic macular disease of any other cause
- •Diabetic retinopathy or diabetic macular edema in either eye
- •Previous organ, tissue or bone marrow transplantation
- •Autoimmune disease
- •Allergy to moxifloxacin
- •Current or prior malignancy (or is on chemotherapy)
研究组 & 干预措施
autologous bone marrow stem cells
use of autologous bone marrow derived stem cells as intravitreal injection in AMD patients
干预措施: autologous bone marrow derived stem cells (Drug)
结局指标
主要结局
number of subjects with adverse events
时间窗: 6 months
Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period
次要结局
- Assessment of visual function changes from the base line(6 months)
研究者
abdelhakim mohamed safwat
assistant lecturer ophthalmology department al-azhar university
Al-Azhar University