Long-Term Safety Follow-Up Study of SCM-AGH in Subjects Who Participated and Administered SCM-AGH in to Severe Atopic Dermatitis Clinical Trials

Study Overview
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Brief Summary
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This is a long-term safety follow-up study of the Phase I/II multicenter study of SCM-AGH in subjects with moderate to severe atopic dermatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol ADT2002 (ClinicalTrials.gov ID: NCT04179760) will be eligible for this long-term follow-up protocol.

Detailed Description
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Subjects who meet all eligibility criteria for Long Term Follow Up(LTFU) study participation at the ADT2002 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.

Official Title
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A Long-Term Safety Follow-Up Study of SCM AGH in Subjects Who Participated in the ADT2002 Study

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Other: Not Applicable (Observational Study)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who provide written informed consent Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study Subjects who are willing to comply with the visit schedule and study requirements for reporting relevant information to the site. Exclusion Criteria: 1. Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Not Applicable (Observational Study)|Not Applicable (Observational Study)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD) | Number of occurrence of treatment-related adverse events (≥ Grade 3 in severity (NCI-CTCAE, v5.0)) | Up to 5 Years | 
| Long-term concomitant medication assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD) | Number of occurrence of use of medications related to adverse events | Up to 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of unresolved Adverse Events(AEs) from ADT2002 study |  | Up to 5 Years | 
| Clinically important physical examination findings | Number of abnormality in general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic. | Up to 5 Years | 
| Number of occurrence of Abnormal, clinically significant in hematology laboratory results | Hematology panel: alkaline phosphatase [ALP], blood urea nitrogen, creatinine, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), albumin, total protein, total bilirubin, uric acid, glucose, cholesterol, sodium, potassium, chloride, calcium, phosphorus | Up to 5 Years | 
| Number of occurrence of Abnormal, clinically significant in chemistry laboratory results | Chemistry panel: hemoglobin, hematocrit, red blood cells, white blood cells (WBC), WBC differential count, platelets | Up to 5 Years | 
| Number of occurrence of Abnormal, clinically significant in urinalysis laboratory results | Urinalysis panel: specific gravity (SG), color, pH, protein, glucose, bilirubin, blood, WBC | Up to 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCM-AGH, Atopic Dermatitis, Stem cell therapy