Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj

Study Overview
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Brief Summary
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A multi-center, open, long-term follow-up study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 Extension Study

Official Title
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Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0104 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 K0104 Clinical Trial(parent study). Subjects who understand and voluntarily sign an informed consent form Exclusion Criteria: Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E) Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial Subjects who are judged to be unsuitable for other researchers to participate in the research

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

| Intervention/Treatment |
| --- |
|Other: Not applicable(observational study)|Not applicable(observational study)|

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) |  | for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50) |  | for 5 years | 
| Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75) |  | for 5 years | 
| Rate of change and Change in EASI from baseline | EASI range is from 0 (clear) to 72 (severe) | for 5 years | 
| Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1 |  | for 5 years | 
| Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher |  | for 5 years | 
| Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50) |  | for 5 years | 
| Rate of change and Change in SCORAD index from baseline at each visit | SCORAD index range is from 0 (clear) to 103 (severe) | for 5 years | 
| Change and rate of change in Body Surface Area (BSA) |  | for 5 years | 
| Change and rate of change in total serum Immunoglobulin E (IgE) |  | for 5 years | 
| Change and rate of change DLQI |  | for 5 years | 
| Change and rate of change POEM |  | for 5 years | 
| Change and rate of change Peak Pruritus NRS |  | for 5 years |