Dermatitis, AtopicNCT07582237
Long-Term Follow-up Study of FURESTEM-AD in Patients With Atopic Dermatitis(K0106)
An observational study of Dermatitis, Atopic, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
Trial summary
Long-Term Follow-up Study of Subjects With Moderate to Severe Chronic Atopic Dermatitis Who Had Administered FURESTEM-AD Inj. in K0106 Study Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dermatitis, Atopic
- How many people
- 262 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2021to 21 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those who participated in the K0106 clinical trial, received FURESTEM-AD Inj., and consented to participate in the long-term follow-up study
Who may be able to join
- Those who participated in the K0106 clinical trial and received FURESTEM-AD Inj
- Those who understand and voluntarily sign an informed consent form
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Follow-up Study of Subjects With Moderate to Severe Chronic Atopic Dermatitis Who Had Administered FURESTEM-AD Inj. in K0106 Study
Long-Term Follow-up Study of Subjects With Moderate to Severe Chronic Atopic Dermatitis Who Had Administered FURESTEM-AD Inj. in K0106 Study
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic Dermatitis, AD, Stem Cell, Furestem
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
Rate and Number of AESI(Adverse Event of Special Interest) and SS(Special Situation)
Measured: 5 years follow-up after treatment
Secondary outcomes (3)
EASI(Eczema Area and Severity Index) Score
Measured: 1 year, 2 years, 3 years after treatment
IGA(Investigator's Global Assessment) Score
Measured: 1 year, 2 years, 3 years after treatment
Pruritus NRS(Numerical Rating Scale) Score
Measured: 1 year, 2 years, 3 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start5 Oct 2021
- Primary completion21 Aug 2028 (estimated)
- Study completion21 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yeonglib Park, professor (CI), Principal investigator, Bucheon Hospital, Soonchunhyang UniversityYangwon Lee, professor, Principal investigator, Konkuk University HospitalSanguk Son, professor, Principal investigator, Korea University Ansan HospitalBakrin Yoo, professor, Principal investigator, Gangdong Kyunghee University HospitalJihyun Lee, professor, Principal investigator, Seoul St. Mary's HospitalDonghoon Lee, professor, Principal investigator, Seoul National University HospitalChanho Na, professor, Principal investigator, Chosun University HospitalYooin Bae, professor, Principal investigator, Hallym University Dongtan Seongsim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582237
- Sponsor's protocol ID
- K0106-E
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up Study of Subjects With Moderate to Severe Chronic Atopic Dermatitis Who Had Administered FURESTEM-AD Inj. in K0106 Study
- ClinicalTrials.gov ID
- NCT07582237
- Acronym / sponsor ID
- K0106-E
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic Dermatitis, AD, Stem Cell, Furestem
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 21 Aug 2028 (estimated)
- Study completion
- 21 Feb 2029 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-Term Follow-up Study of Subjects With Moderate to Severe Chronic Atopic Dermatitis Who Had Administered FURESTEM-AD Inj. in K0106 Study
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who participated in the K0106 clinical trial, received FURESTEM-AD Inj., and consented to participate in the long-term follow-up study
Key inclusion criteria (2 listed)
- Those who participated in the K0106 clinical trial and received FURESTEM-AD Inj
- Those who understand and voluntarily sign an informed consent form
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety Assessment
Time frame: 5 years follow-up after treatment
Rate and Number of AESI(Adverse Event of Special Interest) and SS(Special Situation)
3 secondary outcomes
EASI(Eczema Area and Severity Index) Score
Time frame: 1 year, 2 years, 3 years after treatment
IGA(Investigator's Global Assessment) Score
Time frame: 1 year, 2 years, 3 years after treatment
Pruritus NRS(Numerical Rating Scale) Score
Time frame: 1 year, 2 years, 3 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeonglib Park, professor (CI) principal investigator
Bucheon Hospital, Soonchunhyang University
Yangwon Lee, professor principal investigator
Konkuk University Hospital
Sanguk Son, professor principal investigator
Korea University Ansan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: 5 years follow-up after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.