NCT00978705Unknown3 期
Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- engraftment assessment
研究概览
简要总结
The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.
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
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 1~70 years
- •More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn
- •Must provide signed informed consent prior to participation in any study-related procedures
排除标准
- •Have a pyogenic infection
- •Part of the facial cosmetic surgery cost
- •Hypersensitivity reactions in patients with bovine proteins
- •Hypersensitivity reactions in patients with Gentamycin
- •Pregnancy or lactation
结局指标
主要结局
engraftment assessment
时间窗: 4week
次要结局
- the vancouver burn scar scale(8, 12, 24 week)
研究者
研究点 (2)
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