Clinical trial NCT04730024: Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj
Official title: Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0104 Extension Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-29
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study (K0104-E), it was planned to select subjects who participated in the K0104 clinical trial, a parent study.

Brief summary: A multi-center, open, long-term follow-up study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 Extension Study


Eligibility criteria: Inclusion Criteria:

1. Subject who enrolled K0104 Clinical Trial(parent study).
2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E)
2. Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial
3. Subjects who are judged to be unsuitable for other researchers to participate in the research

Primary outcomes:
measure: Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
timeFrame: for 5 years
Secondary outcomes:
measure: Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)
timeFrame: for 5 years
measure: Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)
timeFrame: for 5 years
measure: Rate of change and Change in EASI from baseline
timeFrame: for 5 years
measure: Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
timeFrame: for 5 years
measure: Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
timeFrame: for 5 years
measure: Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
timeFrame: for 5 years
measure: Rate of change and Change in SCORAD index from baseline at each visit
timeFrame: for 5 years
measure: Change and rate of change in Body Surface Area (BSA)
timeFrame: for 5 years
measure: Change and rate of change in total serum Immunoglobulin E (IgE)
timeFrame: for 5 years
measure: Change and rate of change DLQI
timeFrame: for 5 years
measure: Change and rate of change POEM
timeFrame: for 5 years
measure: Change and rate of change Peak Pruritus NRS
timeFrame: for 5 years
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Medical Center
Study officials:
References: