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Phase 1/2 trials of human bone marrow-derived clonal mesenchymal stem cells for treatment of adults with moderate to severe atopic dermatitis.
Seo, Hyun-Min; Lew, Bark-Lynn; Lee, Yang Won; Son, Sang Wook; Park, Chang Ook; Park, Young Lip; Baek, Jin-Ok; Shin, Min Kyung; Kim, Dong Hyun; Lee, Dong Hun; Jang, Yong Hyun; Ko, Hyun-Chang; Na, Chan-Ho; Seo, Young-Joon; Ham, Dong-Sik; Kim, Dong-Jun; Choi, Gwang Seong.
Afiliación
  • Seo HM; Department of Dermatology, College of Medicine, Hanyang University Guri Hospital, Hanyang University, Seoul, Korea; Hanyang Institute of Bioscience and Biotechnology, Hanyang University, Seoul, Korea.
  • Lew BL; Department of Dermatology, Kyung Hee University School of Medicine, Seoul, Korea.
  • Lee YW; Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea.
  • Son SW; Korea University College of Medicine, Seoul, Korea.
  • Park CO; Department of Dermatology and Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.
  • Park YL; Department of Dermatology, Soonchunhyang University College of Medicine, Bucheon, Korea.
  • Baek JO; Department of Dermatology, Gachon University Gil Medical Center, Incheon, Korea.
  • Shin MK; Department of Dermatology, Kyung Hee University School of Medicine, Seoul, Korea.
  • Kim DH; CHA Bundang Medical Center, CHA University School of Medicine, Pangyo, Korea.
  • Lee DH; Department of Dermatology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
  • Jang YH; Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.
  • Ko HC; Department of Dermatology, School of Medicine, Pusan National University, Yangsan, Korea.
  • Na CH; Department of Dermatology, College of Medicine, Chosun University, Gwangju, Korea.
  • Seo YJ; Department of Dermatology, School of Medicine, Chungnam National University, Daejeon, Korea.
  • Ham DS; SCM Lifescience Inc, Incheon, Korea.
  • Kim DJ; SCM Lifescience Inc, Incheon, Korea.
  • Choi GS; Department of Dermatology, School of Medicine, INHA University, Incheon, Korea. Electronic address: garden@inha.ac.kr.
J Allergy Clin Immunol ; 154(4): 965-973, 2024 Oct.
Article en En | MEDLINE | ID: mdl-38944393
ABSTRACT

BACKGROUND:

Mesenchymal stem cells (MSCs) play important roles in therapeutic applications by regulating immune responses.

OBJECTIVE:

We investigated 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 1 open-label trial followed by a phase 2 randomized, double-blind, placebo-controlled trial that involved 72 subjects with moderate to severe AD.

RESULTS:

In phase 1, intravenous administration of hcMSCs at 2 doses (1 × 106 and 5 × 105 cells/kg) was safe and well tolerated in 20 subjects. Because there was no difference between the 2 dosage groups (P = .9), it was decided to administer low-dose hcMSCs only for phase 2. In phase 2, subjects receiving 3 weekly intravenous infusions of hcMSCs at 5 × 105 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 = .038). The differences between groups in the Dermatology Life Quality Index and pruritus numeric rating scale scores were not statistically significant. Most adverse events were mild or moderate and resolved by the end of the study period.

CONCLUSIONS:

The hcMSC treatment resulted in a significantly higher rate of EASI-50 at 12 weeks compared to the control group in subjects with moderate to severe AD. The safety profile of hcMSC treatment was acceptable. Further larger-scale studies are necessary to confirm these preliminary findings.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante de Células Madre Mesenquimatosas / Dermatitis Atópica / Células Madre Mesenquimatosas Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Allergy Clin Immunol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante de Células Madre Mesenquimatosas / Dermatitis Atópica / Células Madre Mesenquimatosas Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Allergy Clin Immunol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos