Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)

Study Overview
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Brief Summary
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This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis

Official Title
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A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Biological: FURESTEM-AD Inj.
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Of either gender, aged >=19 Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria Chronic Atopic Dermatitis that has been present for at least 3 years EASI>=12 at screening and baseline visit IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks Subjects who understand and voluntarily sign an informed consent form Exclusion Criteria: Subjects with medical history or surgery/procedure history Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region) Subjects who need prohibited medication during clinical period Pregnant, breast-feeding women or women who plan to become pregnant during this study Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FURESTEM-AD Inj.<br>hUCB-MSC 5.0x10^7 cells | Biological: FURESTEM-AD Inj.<br>* 0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL). Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50) |  | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75) |  | 12 week | 
| Change and rafe of change in EASI index |  | 24weeks | 
| Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1 |  | 24weeks | 
| Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points |  | 24weeks | 
| over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50) |  | 24weeks | 
| Change and rafe of change in SCORAD index |  | 24weeks | 
| Change and rafe of change in Body Surface Area (BSA) |  | 24weeks | 
| Change in total serum Immunoglobulin E (IgE) |  | 24weeks | 
| Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis) |  | 24weeks | 
| Total number of use and consumed amount of rescue medicine |  | 24weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AD, Atopic Dermatitis, Stem cell, Cell therapy, skin disease, Umbilical cord Blood, UCB-MSC, hUCB-MSC, furestem, dermatitis, eczema