Long-Term Follow-up Study of FURESTEM-AD in Patients With Atopic Dermatitis(K0106)

May 6, 2026 updated by: Kang Stem Biotech Co., Ltd.

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Bucheon-si, South Korea
        • Bucheon Hospital, Soonchunhyang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • Those who participated in the K0106 clinical trial and received FURESTEM-AD Inj
  • Those who understand and voluntarily sign an informed consent form

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Assessment
Time Frame: 5 years follow-up after treatment
Rate and Number of AESI(Adverse Event of Special Interest) and SS(Special Situation)
5 years follow-up after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
EASI(Eczema Area and Severity Index) Score
Time Frame: 1 year, 2 years, 3 years after treatment
1 year, 2 years, 3 years after treatment
IGA(Investigator's Global Assessment) Score
Time Frame: 1 year, 2 years, 3 years after treatment
1 year, 2 years, 3 years after treatment
Pruritus NRS(Numerical Rating Scale) Score
Time Frame: 1 year, 2 years, 3 years after treatment
1 year, 2 years, 3 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kang Stem Biotech Co., Ltd.

Investigators

  • Principal Investigator: Yeonglib Park, professor (CI), Bucheon Hospital, Soonchunhyang University
  • Principal Investigator: Yangwon Lee, professor, Konkuk University Hospital
  • Principal Investigator: Bakrin Yoo, professor, Gangdong Kyunghee University Hospital
  • Principal Investigator: Jihyun Lee, professor, Seoul St. Mary's Hospital
  • Principal Investigator: Donghoon Lee, professor, Seoul National University Hospital
  • Principal Investigator: Chanho Na, professor, Chosun university hospital
  • Principal Investigator: Yooin Bae, professor, Hallym University Dongtan Seongsim Hospital
  • Principal Investigator: Hyunchang Ko, professor, Yangsan Pusan National University Hospital
  • Principal Investigator: Younghyun Jang, professor, Kyungpook National University Hospital
  • Principal Investigator: Minkyung Shin, professor, KyungHee University Hospital
  • Principal Investigator: Sanghyun Cho, professor, Catholic University Incheon St. Mary's Hospital
  • Principal Investigator: Jooyeon Ko, professor, Hanyang University
  • Principal Investigator: Taeyoung Han, professor, Nowon Eulji University Hospital
  • Principal Investigator: Jiyoung Ahn, professor, National Medical Center
  • Principal Investigator: Sanguk Son, professor, Korea University Ansan Hospital
  • Principal Investigator: Hoon Kang, professor, The Catholic University of Korea Eunpyeong St. Mary's Hospital
  • Principal Investigator: Cheonuk Park, professor, Hallym University Kangnam Sacred Heart Hospital
  • Principal Investigator: Yuchan Kim, professor, Ajou University School of Medicine
  • Principal Investigator: Sungyeol Lee, professor, Soon Chun Hyang University
  • Principal Investigator: Junhong Min, professor, Kangwon National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Estimated)

August 21, 2028

Study Completion (Estimated)

February 21, 2029

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K0106-E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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