Stem cells could offer new hope for severe eczema sufferers
NCT ID NCT04137562
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether a stem cell therapy called ADSTEM can safely and effectively treat moderate-to-severe atopic dermatitis (eczema). About 118 adults with long-lasting eczema that hasn't responded well to standard creams will receive either ADSTEM stem cells or a placebo via IV infusion. Researchers will track how many patients see at least a 50% improvement in their eczema symptoms over 16 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ADSTEM stem cells (mesenchymal stem cells) given by IV infusion
- What this could lead to
- If it works, this could lead to a new treatment option that helps control moderate-to-severe atopic dermatitis with fewer side effects than current therapies.
- What could go wrong
- This is an early Phase 2 trial with only 118 people, so results may not apply to everyone. The treatment is still experimental, and its long-term safety and effectiveness are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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118 people
The number who actually took part.
- Started
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Dec 2019
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 1. SCORAD score ≥ 20points 2. EASI score ≥ 12points 3. 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chung-Ang University Hospital
Seoul, Seoulteukbyeolsi, South Korea
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Chungnam National University Hospital
Daejeon, Chungcheongnam-do, South Korea
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Korea University AnSan Hospital
Ansan, Gyeonggi-do, South Korea
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Kyunghee University Medical Center
Seoul, Seoulteukbyeolsi, South Korea
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SMG-SNU Boramae Medical Center
Seoul, Seoulteukbyeolsi, South Korea
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Seoul National University Hospital
Seoul, Seoulteukbyeolsi, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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