Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
研究概览
简要总结
Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several degenerative diseases, including retinopathies and glaucoma, however no previous safety study involving humans has been conducted. The objective of this study is to evaluate effects of autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence tomography, and retinal ganglion cells function.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Advanced Bilateral Open-Angle Glaucoma;
- •Best corrected visual acuity less than 0,1 in the better eye;
- •Social and cognitive ability to participate.
排除标准
- •Severe systemic morbidities;
- •Other ocular blind conditions associated;
- •Impossibility in performing any of the proposed examinations.
研究组 & 干预措施
MSC transplantion
One group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eyes, through an unique intravitreal injections, under anesthesia.
干预措施: Culture and isolation of autologous bone-marrow mesenchymal stem cells (Biological)
MSC transplantion
One group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eyes, through an unique intravitreal injections, under anesthesia.
干预措施: Intravitreal transplantation of mesenchymal stem cell (Procedure)
结局指标
主要结局
Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
时间窗: 6 months
Retinal detachment
次要结局
- Changes in Visual Acuity(6 months)
- Changes in Optical Coherence Tomography Parameters Related to Glaucoma(6 months)
- Changes in Visual Field(6 months)
- Changes in Retinal Ganglion Cells Function by ERG(6 months)
研究者
JAYTER SILVA DE PAULA
Associate Professor
University of Sao Paulo