Long-term Observational Study to Evalution the Safety and Efficacy of FURESTEM-AD Inj.
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT03458624
- Lead Sponsor
- Kang Stem Biotech Co., Ltd.
- Brief Summary
Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis
- Detailed Description
This is a observational study, single center, open label, study of safety and Efficacy of FURESTEM-AD Inj. in subjects with moderate to severe Atopic Dermatitis.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
- Subject who understands and voluntarily sign an informed consent form
Exclusion Criteria
- In case follow-up is not possible from end of clinical trial Phase 1/2a to end of this study period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the number of adverse events Safety of FURESTEM-AD Inj. 3 years The severity of each adverse enent was classified according to CTCAE v4.0
- Secondary Outcome Measures
Name Time Method Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline 3 years Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value 3 years Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point 3 years Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value 3 years Variation of EASI(Eczema area and severity index) as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value 3 years
Trial Locations
- Locations (1)
Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of