Study of ADSTEM Injection for Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

Inclusion criteria

• Adults aged 19 to 70 years at the time of informed consent.
• Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria at screening.
• History of atopic dermatitis for at least 24 weeks prior to screening.
• Moderate-to-severe atopic dermatitis at screening, defined as:

• EASI score ≥16
• SCORAD score ≥25
• Body Surface Area (BSA) involvement ≥10%
• vIGA score ≥3
• Inadequate response to prior standard topical and/or systemic treatments for atopic dermatitis, or inability to receive such treatments due to safety concerns.
• Voluntary written informed consent provided.

Exclusion criteria

• Presence of clinically significant comorbidities at screening, including:

• Active infection requiring antimicrobial treatment within 2 weeks prior to baseline, or superficial skin infection within 1 week prior to baseline;
• Skin diseases that require ongoing treatment or may interfere with safety or efficacy assessments;
• Uncontrolled asthma requiring oral corticosteroids;
• Positive test results for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis;
• Other uncontrolled or clinically significant medical conditions that may affect study participation or assessments;
• Clinically significant abnormal laboratory results at screening (e.g., AST or ALT > 3 × ULN, serum creatinine > 2 × ULN).
• History of prohibited treatments prior to baseline, including:

• Use of JAK inhibitors within 4 weeks;
• Use of biologic therapies for atopic dermatitis within 12 weeks;
• Use of systemic immunosuppressants, immunomodulators, or systemic corticosteroids within 4 weeks;
• Use of topical corticosteroids, topical PDE-4 inhibitors, or topical calcineurin inhibitors within 2 weeks;
• Participation in another clinical trial with an investigational drug or device within 4 weeks prior to screening;
• Prior treatment with cell therapy or gene therapy.
• History of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer without recurrence.
• History of tanning within 4 weeks prior to baseline.
• Pregnant or breastfeeding women, or women planning pregnancy during the study period.
• Women of childbearing potential who are unwilling to use adequate contraception from the time of informed consent through the end of the study.
• Known or suspected hypersensitivity to the investigational product or any of its components.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.