AzTrials
AzTrials

Atopic DermatitisPhase 2NCT04137562

Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

A Phase 2 study testing ADSTEM Inj. in people with Atopic Dermatitis, run by EHL Bio Co., Ltd. at 6 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
ADSTEM Inj.
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
6 sitesSouth Korea
Study dates
11 Dec 2019to 31 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Korea University AnSan Hospital

    Ansan, Gyeonggi-do

  • Chungnam National University Hospital

    Daejeon, Chungcheongnam-do

  • Chung-Ang University Hospital

    Seoul, Seoulteukbyeolsi

  • Kyunghee University Medical Center

    Seoul, Seoulteukbyeolsi

  • Seoul National University Hospital

    Seoul, Seoulteukbyeolsi

  • SMG-SNU Boramae Medical Center

    Seoul, Seoulteukbyeolsi

Other trials in South Korea

About this study

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

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.

Read the detailed description

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.

Being tested
ADSTEM Inj., Placebo
Keywords
Adipose Derived Mesenchymal Stem cell, ADMSC, AD, Inflammatory disease, ADMC, Stem cell, ehlbio
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADSTEM Inj.Biological

    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

  • PlaceboOther

    330mL of 0.9% normal saline is injected intravenously twice for the duration of the study.

Study groups in NCT04137562
Study groupRoleWhat they receive
ADSTEM Inj.ExperimentalADSTEM Inj. hAD-MSC 1.0x10^8 cells
Receives: Biological: ADSTEM Inj.
PlaceboPlacebo comparator0.9% Normal Saline Inj.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EASI-50

    Percentage of subjects whose EASI score decreased by 50% or more at 16 weeks compared to baseline

    Measured: 16 weeks

Secondary outcomes (16)

  1. EASI-50

    Percentage of subjects whose EASI score decreased by 50% or more at 4, 8 and 12 weeks compared to baseline

    Measured: 4, 8, 12 weeks

  2. EASI-75

    Percentage of subjects whose EASI score decreased by 75% or more at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  3. EASI score

    EASI score change at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  4. SCORAD-50

    Percentage of subjects whose SCORAD score decreased by 50% or more at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  5. SCORAD-75

    Percentage of subjects whose SCORAD score decreased 75% or more at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  6. SCORAD score

    SCORAD score change at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  7. 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

    Measured: 4, 8, 12, 16 weeks

  8. Severity

    Severity change of disease at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  9. IGA grade

    Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  10. 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

    Measured: 4, 8, 12, 16 weeks

  11. 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

    Measured: 4, 8, 12, 16 weeks

  12. Total IgE

    Total IgE change at 4, 8, 12, 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  13. PGE2 and ECP

    Prostaglandin E2 (PGE2) and Eosinophil Cationic Protein (ECP) changes at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  14. Immune cytokine

    TGF-1, interleukin (IL)-4, 5, 6, 8, 13, 31 and CCL17 at 4, 8, 12 and 16 weeks compared to baseline

    Measured: 4, 8, 12, 16 weeks

  15. Remedy used days and frequency

    Days and frequency of used remedies at 4, 8, 12 and 16 weeks

    Measured: 4, 8, 12, 16 weeks

  16. Remedy used subjects

    Percentage of subjects whom used remedies at 4, 8,12 and 16 weeks

    Measured: 4, 8, 12, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2019
  2. Study start11 Dec 2019
  3. Primary completion26 Jan 2023
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04137562
Sponsor's protocol ID
AD-CP-18-1
Other IDs
30902
Status last verified
Jun 2026
First submitted
21 Oct 2019
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41331725

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADSTEM Inj. in people with Atopic Dermatitis, run by EHL Bio Co., Ltd. at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EASI-50 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04137562, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in