Evalution the Safety and Efficacy in Atopic Dermatitis Patients

Study Overview
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Brief Summary
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A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study

Official Title
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A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0102 Extension Study

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Not applicable(observational study)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who enrolled K0102 Clinical Trial(parent study). Subjects who understand and voluntarily sign an informed consent form Exclusion Criteria: In case follow-up is not possible from end of K0102 clinical trial to end of this study period Any other condition which the investigator judges would make patient unsuitable for study participation

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atopic Dermatitis<br> | Other: Not applicable(observational study)<br>* Not applicable(observational study)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50) |  | 3 years | 
| Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75) |  | 3 years | 
| Rate of change in EASI from baseline |  | 3 years | 
| Change in EASI from baseline | EASI range is from 0 (clear) to 72 (severe) | 3 years | 
| Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1 |  | 3 years | 
| Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher |  | 3 years | 
| Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50) |  | 3 years | 
| Rate of change in SCORAD index from baseline at each visit |  | 3 years | 
| Change in SCORAD index from baseline at each visit | SCORAD index range is from 0 (clear) to 103 (severe) | 3 years | 
| Rate of change in Body Surface Area(BSA) of the lesion from baseline |  | 3 years | 
| Change in Body Surface Area(BSA) of the lesion from baseline | BSA range is from 0 (clear) to 100 (severe) | 3 years | 
| Change in total serum Immunoglobulin E(IgE) from baseline |  | 3 years |