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Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Sponsor: EHL Bio Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
19 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2019-12-11
Completion Date
2027-10-31
Last Updated
2024-03-15
Healthy Volunteers
No
Conditions
Interventions
ADSTEM Inj.
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
Placebo
330mL of 0.9% normal saline is injected intravenously twice for the duration of the study.
Locations (6)
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
Seoul National University Hospital
Seoul, Seoulteukbyeolsi, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoulteukbyeolsi, South Korea