NCT03237442Unknown1 期
Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the percent of cornea perforation
研究概览
简要总结
Ocular chemical burn is one of the causes of vision loss in China, and there are no satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal burn in human.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（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 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.
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 surgery on eyeball after trauma;
- •IOP>=25 mmHg even after antiglaucoma;
- •have the history of other corneal disease or surgery;
- •have the history of radiotherapy or surgery in the eyeball;
- •associated with corneal ulcer or endoophthalmitis;
- •uncontrolled hypertension(>=150/95 mmHg);
- •abnormal liver and renal function;
- •the pregnant women.
研究组 & 干预措施
group 2
Active Comparator
干预措施: placebo (Biological)
group 1
Experimental
干预措施: human umbilical cord mesenchymal stem cells (Biological)
结局指标
主要结局
the percent of cornea perforation
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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