NCT02619851已完成2 期
A Phase II Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects: Controlled, Parallel, Multicenter
Anterogen Co., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年12月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time of re-epithelialization
研究概览
简要总结
This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.
详细描述
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating Deep Second-degree burn wounds.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age and older.
- •Subjects who have deep second-degree burn wound ≥100cm^
- •TBSA(Total burn surface area) ≤ 30%
- •Negative for Urine beta-HCG for women of childbearing age.
- •Subject is able to give written informed consent prior to study start and comply with the study requirements.
排除标准
- •Subject who have been enrolled in another clinical study within 30 days of screening.
- •Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
- •Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term
- •Subjects with active infection.
- •Subjects with hemorrhagic and hemocoagulative disease.
- •Subjects who are unwilling to use an "effective" method of contraception during the study.
- •Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
- •Subjects who are pregnant or breast-feeding.
- •Subjects who are considered to have a significant disease which can impact the wound healing by the investigator
- •Burn wound is present on any part of the face.
- •Subjects who are considered not suitable for the study by the investigator.
- •Subjects who are not able to understand the objective of this study or to comply with the study requirements
结局指标
主要结局
Time of re-epithelialization
时间窗: Follow up to 12 weeks
Time of re-epithelialization
次要结局
- Burn Scar Index(Follow up to 12 weeks)
- healing status of the wound evidenced by photography(follow up to 12 weeks)
- Safety (laboratory tests and adverse events)(Follow up to 12 weeks)
研究者
研究点 (1)
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