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

NCT04185584 | Unknown

• 1 other identifier: ADT2002-LTFU
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Keywords

SCM-AGH; Atopic Dermatitis; Stem cell therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Outcome of unresolved Adverse Events(AEs) from ADT2002 study

  Up to 5 Years

• Clinically important physical examination findings

  Up to 5 Years

• Number of occurrence of Abnormal, clinically significant in hematology laboratory results

  Up to 5 Years

• Number of occurrence of Abnormal, clinically significant in chemistry laboratory results

  Up to 5 Years

• Number of occurrence of Abnormal, clinically significant in urinalysis laboratory results

  Up to 5 Years

Interventions

Not Applicable (Observational Study) OTHER

Not Applicable (Observational Study)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study (ClinicalTrials.gov ID: NCT04179760)

You may qualify if:

• 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.

You may not qualify if:

• \. Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH

Sponsors & Collaborators

• SCM Lifescience Co., LTD.: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Observation

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Gwang Seong Choi, MD-Ph.D

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 4, 2019
• Study Start: August 25, 2020
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

KR (1)