Dermatitis, Atopic
Conditions
Keywords
SCM-AGH, Atopic Dermatitis, Stem cell therapy
Brief summary
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
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.
Interventions
Not Applicable (Observational Study)
Sponsors
SCM Lifescience Co., LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who provide written informed consent 2. Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD) | Up to 5 Years | Number of occurrence of treatment-related adverse events (≥ Grade 3 in severity (NCI-CTCAE, v5.0)) |
| Long-term concomitant medication assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD) | Up to 5 Years | Number of occurrence of use of medications related to adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of occurrence of Abnormal, clinically significant in hematology laboratory results | Up to 5 Years | 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 |
| Outcome of unresolved Adverse Events(AEs) from ADT2002 study | Up to 5 Years | — |
| Number of occurrence of Abnormal, clinically significant in urinalysis laboratory results | Up to 5 Years | Urinalysis panel: specific gravity (SG), color, pH, protein, glucose, bilirubin, blood, WBC |
| Number of occurrence of Abnormal, clinically significant in chemistry laboratory results | Up to 5 Years | Chemistry panel: hemoglobin, hematocrit, red blood cells, white blood cells (WBC), WBC differential count, platelets |
| Clinically important physical examination findings | Up to 5 Years | Number of abnormality in general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic. |
Countries
South Korea
Outcome results
None listed