NCT03252340已完成不适用
Observational Study to Evaluate the Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Tumor formation
研究概览
简要总结
This study aims to evaluate safety in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an observational study of patients participated in Phase 1 clinical trials, no drug is administered in this study.
详细描述
Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12, 18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj.
Time perspective is both retrospective and prospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who participated in Phase I clinical trials
- •Patients who voluntarily agreed to participate in the study
排除标准
- •Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study
研究组 & 干预措施
Drug: ADSTEM Inj.
Participants in Phase I clinical trials treated with ADSTEM Inj.
干预措施: ADSTEM Inj. (Drug)
结局指标
主要结局
Tumor formation
时间窗: 60months after treatment of ADSTEM Inj.
The number of subjects with treatment-related tumor formation
次要结局
- Adverse events(60months after treatment of ADSTEM Inj.)
研究者
研究点 (1)
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