NCT02394873已完成1 期
A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Deep Second-degree Burn Wound
Anterogen Co., Ltd.1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells 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 a burn.
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 —（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 ≥100 cm^
- •Negative for urine beta-HCG for women of childbearing age.
- •Subject is able to give written informed consent prior to study start and to comply with the study requirements.
排除标准
- •Subjects 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.
- •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 study by the investigator
- •Burn wound is present on any part of the face.
- •Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
- •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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: up to 4 weeks
次要结局
- Vancouver Burn Scar Scale(4 weeks)
- Time to reach re-epithelialization of wound(1, 2, 4 weeks)
研究者
研究点 (1)
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