Safety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD)

Summary

This clinical trial study is two-stage, multi-center, randomized, double-blind, placebo controlled, phase 3 clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis.

Conditions

• Dermatitis, Atopic

Interventions

BIOLOGICAL

FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL

the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)

BIOLOGICAL

Placebo

the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)

Sponsors & Collaborators

• Kang Stem Biotech Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Yeonglib Park, professor (CI) · Bucheon Hospital, Soonchunhyang University

• Yangwon Lee, professor · Konkuk University Hospital

• Sanguk Son, professor · Korea University

• Bakrin Yoo, professor · Gangdong Kyunghee University Hospital

• Jihyun Lee, professor · Seoul St. Mary's Hospital

• Donghoon Lee, professor · Seoul National University Hospital

• Chanho Na, professor · Chosun University Hospital

• Yooin Bae, professor · Hallym University Dongtan Seongsim Hospital

• Hyunchang Ko, professor · Yangsan Pusan National University Hospital

• Younghyun Jang, professor · Kyungpook National University Hospital

• Jeongeun Kim, professor · The Catholic University of Korea Eunpyeong St. Mary's Hospital

• Minkyung Shin, professor · Kyunghee University Hospital

• Sanghyun Cho, professor · Catholic University Incheon St. Mary's Hospital

• Cheonuk Park, professor · Hallym University Gangnam Seongsim Hospital

• Jooyeon Ko, professor · Hanyang University

• Taeyoung Han, professor · Nowon Eulji University Hospital

• Jiyoung Ahn, professor · National medical center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-29

Primary Completion

2023-01-31

Completion

2023-04-30

Countries

• South Korea