Evalution the Safety and Efficacy in Atopic Dermatitis Patients

A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0102 Extension Study

A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Not applicable(observational study)

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

moderate to severe chronic atopic dermatitis

Description

Inclusion Criteria:

1. Subject who enrolled K0102 Clinical Trial(parent study).
2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. In case follow-up is not possible from end of K0102 clinical trial to end of this study period
2. Any other condition which the investigator judges would make patient unsuitable for study participation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atopic Dermatitis	Other: Not applicable(observational study); Not applicable(observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EASI from baseline	EASI range is from 0 (clear) to 72 (severe)	3 years
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1		3 years
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)		3 years
Rate of change in SCORAD index from baseline at each visit		3 years
Change in SCORAD index from baseline at each visit	SCORAD index range is from 0 (clear) to 103 (severe)	3 years
Change in total serum Immunoglobulin E(IgE) from baseline		3 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)		3 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)		3 years
Rate of change in EASI from baseline		3 years
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher		3 years
Rate of change in Body Surface Area(BSA) of the lesion from baseline		3 years
Change in Body Surface Area(BSA) of the lesion from baseline	BSA range is from 0 (clear) to 100 (severe)	3 years

Collaborators and Investigators

• Sponsor: Kang Stem Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Anticipated): January 2, 2024
• Study Completion (Anticipated): January 2, 2024

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: K0102-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No