A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis. The aim of this study is to evaluate the safety and efficacy of ADSTEM Inj. against Placebo in the treatment of atopic dermatitis in patients with moderate to severe acute and chronic atopic.
This clinical trial is designed with multi-organization, random assignment, single-blind, second-phase clinical trials and open long-term follow up studies, and is intended for patients with secondary or above subacuteal and chronic atopic dermatitis. If the test subjects voluntarily agree in writing to participate in this clinical trial, they shall conduct the examination and examination required for four weeks prior to administration of the investigational product (visit 1) in accordance with the clinical trial plan. As a result of the suitability assessment of the test subjects, those who comply with the inclusion/exclusion criteria, adipose tissue will be collected through the liposuction method and randomly assigned to each arms. Subjects who are eligible for administration of the investigational product on the day of administration (visit 2) under the investigator's judgment are given intravenous administration of the clinical trial medication once at the date of administration (visit 2, visit 3) and follow-up inspection is conducted at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the first administration of the investigational product and safety and efficacy assessments are conducted for a total of 16 weeks. The test subjects assigned to the placebo group shall be compensated by administering a experimental drug on demand after the visit 6. It is a principle to administer the test drug prepared from the previously obtained adipose tissue, and it is possible to carry out further adipose tissue collection if necessary. However, no safety and efficacy assessments of compensatory treatments will be collected. Safety and efficacy will be analyzed after all the subjects has completed visit 6. For the experimental group only, long-term observation study for safety assessment is conducted at the point of 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months after the second administration of the investigational product for a total of 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
118
Two 5mL of the following study drug is pre-mixed with 320mL of 0.9% normal saline is injected intravenously twice for the duration of the study. Treatment group: ADSTEM Inj. 0.5x10\^8 cells/5mL
330mL of 0.9% normal saline is injected intravenously twice for the duration of the study.
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, South Korea
Korea University AnSan Hospital
Ansan, Gyeonggi-do, South Korea
Chung-Ang University Hospital
Seoul, Seoulteukbyeolsi, South Korea
Kyunghee University Medical Center
Seoul, Seoulteukbyeolsi, South Korea
EASI-50
Percentage of subjects whose EASI score decreased by 50% or more at 16 weeks compared to baseline
Time frame: 16 weeks
EASI-50
Percentage of subjects whose EASI score decreased by 50% or more at 4, 8 and 12 weeks compared to baseline
Time frame: 4, 8, 12 weeks
EASI-75
Percentage of subjects whose EASI score decreased by 75% or more at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
EASI score
EASI score change at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
SCORAD-50
Percentage of subjects whose SCORAD score decreased by 50% or more at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
SCORAD-75
Percentage of subjects whose SCORAD score decreased 75% or more at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
SCORAD score
SCORAD score change at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
SCORAD subgroup
SCORAD evaluation items(Extent Criteria, erythema, edema/population, oozing/crusting, excoriation, lichenification, dryness, pruritus, insomnia) score change at 4, 8, 12 and 16 weeks compared to baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seoul National University Hospital
Seoul, Seoulteukbyeolsi, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoulteukbyeolsi, South Korea
Time frame: 4, 8, 12, 16 weeks
Severity
Severity change of disease at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
IGA grade
Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
IGA -1 or more grade
Percentage of subjects who dropped one or more grades on the Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
IGA -2 or more grade
Percentage of subjects who dropped two or more grades on the Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
Total IgE
Total IgE change at 4, 8, 12, 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
PGE2 and ECP
Prostaglandin E2 (PGE2) and Eosinophil Cationic Protein (ECP) changes at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
Immune cytokine
TGF-1, interleukin (IL)-4, 5, 6, 8, 13, 31 and CCL17 at 4, 8, 12 and 16 weeks compared to baseline
Time frame: 4, 8, 12, 16 weeks
Remedy used days and frequency
Days and frequency of used remedies at 4, 8, 12 and 16 weeks
Time frame: 4, 8, 12, 16 weeks
Remedy used subjects
Percentage of subjects whom used remedies at 4, 8,12 and 16 weeks
Time frame: 4, 8, 12, 16 weeks