A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Evaluation of systemic tolerance through incidence of abnormal laboratory test results
研究概览
简要总结
This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months
详细描述
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months. 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 a Diabetic Foot Ulcer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-
- •Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.
排除标准
- •Subjects who are considered not suitable for the study by the principal investigator.
研究组 & 干预措施
ALLO-ASC-DFU
Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-302
干预措施: ALLO-ASC-DFU (Biological)
Vehicle sheet
Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-302
干预措施: Vehicle sheet (Procedure)
结局指标
主要结局
Evaluation of systemic tolerance through incidence of abnormal laboratory test results
时间窗: Up to 9 months
Evaluation of incidence of clinically significant change in physical examination and vital signs
时间窗: Up to 18 months
Evaluation of localized tolerance through incidence of clinically significant change about treatment area
时间窗: Up to 24 months
Evaluation of incidence of adverse events
时间窗: Up to 24 months
次要结局
未报告次要终点