The Subconjunctival Injection of Human Bone Marrow Mesenchymal Stem Cells for Ocular Corneal Burn: Prospective, Case Series Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Incidence of adverse events by subconjunctival injection of BMMSCs
研究概览
简要总结
Ocular chemical burn is one of the cause of vision loss in our country, and there are no satisfactory treatment. Human bone marrow mesenchymal stem cells (MSC) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of mesenchymal stem cell in the treatment of corneal burn in human.
详细描述
Corneal burn is a ocular damage disease included chemically burned and thermally burned. Surgery of corneal transplantation，amniotic membrane transplantation are some of effective,however,these therapy are expensive and the transplantation resources are limited. To arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. Corticosteroids also is important, however, long time usage of corticosteroids often cause severe side-effects. Human bone marrow mesenchymal stem cells (MSC) have the biological characteristics of self -renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC can accelerated the cornea repair, inhibited angiogenesis. Many animal research also revealed that MSC have effect on the ocular alkali burned. And subconjunctivity injection is efficient, the clinical study of MSC on treating other disease have been developed rapidly recently, in further ,the outcome are encouraging, and no side-effect related MSC was reported, MSC can come from bone marrow, Umbilical cord blood，Adipose tissue and so on, but bone marrow MSC is mostly common used. The investigators propose to assess the efficacy and safety of human bone marrow mesenchymal stem cell in the treatment of corneal burn in human.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be ocular burns including chemically burned or the thermally burned
- •the severity degree should above the Ⅳ degree,including the Ⅳ degree(according the classification of Dua standard,2001)
- •the subjects are willing to accept this research,and promise to coordinate with the researchers during the follow up period
- •the subjects should abide by the laws and rules of the study.
- •the incident time should be within 2 weeks -
排除标准
- •the visual acuity is blind in any of the eye
- •have corneal perforation or have the corneal perforation tendency
- •have been accepted surgury on eyeball after trauma
- •IOP≥25mmHg even after antiglaucoma
- •have the history of other corneal diseaze or surgury
- •have the history of radiotherapy or surgury in the eyeball
- •associated with corneal ulcer or endoophthalmitis
- •uncontrolled hypertension(≥150/95mmHg)
- •abnormal liver and renal function
- •the pregancy women -
结局指标
主要结局
Incidence of adverse events by subconjunctival injection of BMMSCs
时间窗: 6 months
Record the adverse events, including topical complications such as ocular infection, conjunctival necrosis at the injection site, retinal artery occlusion, and systemic complications such as fever, urticaria, hemolysis, hypotension, renal and liver dysfunction, tumor formation, and/or abnormalities in complete blood counts.
次要结局
- Incidence of corneal perforation rate after subconjunctival injection of BMMSCs(6 months)
- Time of corneal epithelialization(6 month)
- Visual acuity(6 month)
研究者
Dan Liang
M.D
Sun Yat-sen University