한빛사논문
- 조회149
Hyun-Min Seo MD, PhD 1,2, Bark-Lynn Lew MD, PhD 3, Yang Won Lee MD, PhD 4, Sang Wook Son MD, PhD 5, Chang Ook Park MD, PhD 6, Young Lip Park MD, PhD 7, Jin-Ok Baek MD, PhD 8, Min Kyung Shin MD, PhD 3, Dong Hyun Kim MD, PhD 9, Dong Hun Lee MD, PhD 10, Yong Hyun Jang MD, PhD 11, Hyun-Chang Ko MD, PhD 12, Chan-Ho Na MD, PhD 13, Young-Joon Seo MD, PhD 14, Dong-Sik Ham PhD 15, Dong-Jun Kim BS 15, Gwang Seong Choi MD, PhD 16
1Department of Dermatology, College of Medicine, Hanyang University, Hanyang University Guri Hospital, Republic of Korea
2Hanyang Institute of Bioscience and Biotechnology, Hanyang University, Seoul, Republic of Korea
3Department of Dermatology, Kyung Hee University School of Medicine, Seoul, Republic of Korea
4Department of Dermatology, Konkuk University School of Medicine, Seoul, Republic of Korea
5Korea University College of Medicine, Seoul, Republic of Korea
6Department of Dermatology and Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
7Department of Dermatology, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea
8Department of Dermatology, Gachon University Gil Medical Center, Incheon, Republic of Korea
9CHA Bundang Medical Center, CHA University School of Medicine, Republic of Korea
10Department of Dermatology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea
11Department of Dermatology, School of Medicine, Kyungpook National University, Republic of Korea
12Department of Dermatology, School of Medicine, Pusan National University, Yangsan, Republic of Korea
13Department of Dermatology, College of Medicine, Chosun University, Republic of Korea
14Department of Dermatology, School of Medicine, Chungnam National University, Republic of Korea
15SCM Lifescience, Inc, Incheon, Republic of Korea
16Department of Dermatology, School of Medicine, INHA University, Republic of Korea
Corresponding Author: Gwang Seong Choi, MD, PhD
Abstract
Background: Mesenchymal stem cells (MSCs) play important roles in therapeutic applications by regulating immune responses.
Objective: To investigate the safety and efficacy of allogenic human bone marrow-derived clonal MSCs (hcMSCs) in subjects with moderate to severe atopic dermatitis (AD).
Methods: The study included a phase I open-label trial followed by a phase II randomized, double-blind, placebo-controlled trial that involved 72 subjects with moderate to severe AD.
Results: In phase I, intravenous (IV) administration of hcMSCs at two doses (1×106 and 5×105 cells/kg) was safe and well-tolerated in 20 subjects. Since there was no difference between the two dosage groups (P=0.9), it was decided to administer low-dose hcMSCs only for phase II. In phase II, subjects receiving three weekly IV infusions of hcMSCs at 5x105 cells/kg showed a higher proportion of an eczema area and severity index (EASI)-50 response at week 12 compared to the placebo group (P=0.038). The differences between groups in the dermatology life quality index and pruritus numerical-rating scale scores were not statistically significant. Most adverse events were mild or moderate and resolved by the end of the study period.
Conclusions: Our findings demonstrate that hcMSCs treatment resulted in a significantly higher rate of achieving EASI-50 at 12 weeks compared to the control group in subjects with moderate to severe AD. The safety profile of hcMSCs treatment was acceptable. Further larger-scale studies are necessary to confirm these preliminary findings.
논문정보
- Research article
- 2024년 06월 (BRIC 등록일 2024-07-03)
- 국내 연구진
- 의약학 > 응용의학
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