Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Stem cell, Cell therapy, skin disease, Umbilical cord Blood, UCB-MSC, hUCB-MSC, AD, furestem, dermatitis, eczema
Brief summary
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
Interventions
BIOLOGICALFURESTEM-AD Inj.
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
OTHERPlacebo
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)
Sponsors
Kang Stem Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Of either gender, aged \>=19 2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria 3. Chronic Atopic Dermatitis that has been present for at least 3 years 4. EASI\>=12 at screening and baseline visit 5. IGA\>=3, SCORAD index\>=25, BSA \>=10% of AD involvement at screegning and baseline visit 6. 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 7. Subjects who understand and voluntarily sign an informed consent form
Exclusion criteria
1. Subjects with medical history or surgery/procedure history 2. 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) 3. Subjects who need prohibited medication during clinical period 4. Pregnant, breast-feeding women or women who plan to become pregnant during this study 5. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks 6. Any other condition which the investigator judges would make patient unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50) | 12 week |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Change and rafe of change in Body Surface Area (BSA) | 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 |
| Total number of use and consumed amount of rescue medicine | 24weeks |
| Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1 | 24weeks |
Countries
South Korea
Outcome results
None listed