Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
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
2 other identifiers
interventional
118
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2019
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
October 24, 2019
CompletedStudy Start
First participant enrolled
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
ExpectedMarch 15, 2024
March 1, 2024
3.1 years
October 21, 2019
March 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EASI-50
Percentage of subjects whose EASI score decreased by 50% or more at 16 weeks compared to baseline
16 weeks
Secondary Outcomes (16)
EASI-50
4, 8, 12 weeks
EASI-75
4, 8, 12, 16 weeks
EASI score
4, 8, 12, 16 weeks
SCORAD-50
4, 8, 12, 16 weeks
SCORAD-75
4, 8, 12, 16 weeks
- +11 more secondary outcomes
Study Arms (2)
ADSTEM Inj.
EXPERIMENTALADSTEM Inj. hAD-MSC 1.0x10\^8 cells
Placebo
PLACEBO COMPARATOR0.9% Normal Saline Inj.
Interventions
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.
Eligibility Criteria
You may qualify if:
- At the time of visit 1, only men and women aged between 19 and 70
- Patients with atopic dermatitis meeting the Hanifin and Rajka diagnostic criteria
- Subacute and chronic patients with symptoms of atopic dermatitis lasting at least 6 months
- Patients with moderate to severe atopic dermatitis who meet all of the following criteria
- SCORAD score ≥ 20points
- EASI score ≥ 12points
- BSA ≥ 10%
- Patients with inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks prior to study initiation, or those who are unable to administer topical atopic dermatitis treatment due to safety reasons
- Patients who voluntarily agreed in writing to participate in this clinical trial
You may not qualify if:
- Patients with systemic infection symptoms at the time of clinical trials
- Patients with HIV, HBV, HCV, Syphilis test positive
- Patients with uncontrolled asthma disease at the time of clinical trial participation
- Patients who were considered inevitable to receive the medication from 1 month prior to administration of the clinical trial drug to visit 6 such as Immune function modifier(tacrolimus, pimecrolimus, cyclosporine, etc.), and high-frequency topical steroids in Groups 1 to 5, systemic steroids, systemic photochemotherapy, medication that are thought to affect other immune functions (such as immunoglobulin therapy like dupilumab, tralloquinap and desensitization therapy, etc.)
- Women who are pregnant, breastfeeding or have a pregnancy plan up to visit 6 or who do not use available contraceptive methods (women of childbearing age must be negative in screening pregnancy test)
- If patients are the male subject, Those who do not agree to have a contraception during the clinical trial (If the male subject or female partner is infertile, the above-mentioned contravention method is unnecessary)
- Patients participating in other clinical trials or participating in other clinical trials within the last 30 days
- Patients who have experienced significant adverse events during treatment with stem cell therapies
- Patients with stem cell therapy doses or history of participating in clinical trials
- Patients with a history of hypersensitivity to antibiotics and antifungal agents used in the manufacture of medicines for clinical trials
- Patients with renal dysfunction whose creatinine level is more than twice the normal upper limit in the screening test
- Patients with hepatic dysfunction whose AST (Aspartate Amino Transaminase) and ALT (Alanine Amino Transaminase) levels are more than three times the normal upper limit
- Patients who are not suitable for this clinical trial under the judgment of the other examiners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Publications (1)
Seok J, Kim SY, Lee WG, Shin MK, Lee DH, Seo YJ, Cho S, Park KY, Son SW, Lee SH, Seo JS, Seo SJ. Efficacy and safety of autologous adipose-derived stem cells in subjects with moderate to severe atopic dermatitis: a multicenter, randomized, single-blind, placebo-controlled, phase 2 trial. Stem Cell Res Ther. 2025 Dec 2;16(1):671. doi: 10.1186/s13287-025-04763-y.
PMID: 41331725DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seongjun Seo, M.D, Ph.D
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- PRINCIPAL INVESTIGATOR
Sanguk Son, M.D, Ph.D
Korea University Ansan Hospital
- PRINCIPAL INVESTIGATOR
Soyeon Jo, M.D, Ph.D
SMG-SNU Boramae Medical Center
- PRINCIPAL INVESTIGATOR
Young-joon Seo, M.D, Ph.D
Chungnam National University Hospital
- PRINCIPAL INVESTIGATOR
Donghun Lee, M.D, Ph.D
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Mingyeong Shin, M.D, Ph.D
Kyunghee University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and efficacy outcome assessor will be blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2019
First Posted
October 24, 2019
Study Start
December 11, 2019
Primary Completion
January 26, 2023
Study Completion (Estimated)
October 31, 2027
Last Updated
March 15, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share