Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: ADSTEM Inj.
- Registration Number
- NCT03252340
- Lead Sponsor
- EHL Bio Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- Patients who participated in Phase I clinical trials
- Patients who voluntarily agreed to participate in the study
Exclusion Criteria
- Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Drug: ADSTEM Inj. ADSTEM Inj. Participants in Phase I clinical trials treated with ADSTEM Inj.
- Primary Outcome Measures
Name Time Method Tumor formation 60months after treatment of ADSTEM Inj. The number of subjects with treatment-related tumor formation
- Secondary Outcome Measures
Name Time Method Adverse events 60months after treatment of ADSTEM Inj. The number of subjects with treatment-related adverse events
Trial Locations
- Locations (1)
Chungnam National University Hospital
🇰🇷Daejeon, Chungcheongnam-do, Korea, Republic of