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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FURESTEM-AD Inj. | Experimental | hUCB-MSC 5.0x10^7 cells |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FURESTEM-AD Inj. | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50) | 12 week |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | South Korea | ||||
| Chonnam National University Hospital |
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| Placebo | Other | 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) |
|
| 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 |
| Gwangju |
| South Korea |
| Dongguk University Medical Center | Ilsan | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Catholic Medical Center | Seoul | 137-701 | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Chung-Ang University Healthcare System | Seoul | South Korea |
| Hanyang University Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D012871 | Skin Diseases |
| D003872 | Dermatitis |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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