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조회 1842  인쇄하기 주소복사 트위터 공유 페이스북 공유 
Transplantation with Autologous Bone Marrow-Derived Mesenchymal Stem Cells for Alcoholic Cirrhosis: Phase 2 Trial

Ki Tae Suk1,†, Jung-Hwan Yoon2,†, Moon Young Kim3, Chang Wook Kim4, Ja Kyung Kim5, Hana Park6, Seong Gyu Hwang6, Dong Joon Kim1, Byung Seok Lee7, Sae Hwan Lee8, Hong Soo Kim8, Jae Young Jang9, Chang-Hyeong Lee10, Byung Seok Kim10, Yoon Ok Jang3, Mee Yon Cho11, Eun Sun Jung12, Yong Man Kim13, Si Hyun Bae14,‡,* and Soon Koo Baik3,‡,*

1 Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
2 Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea
3 Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University, Wonju College of Medicine, Wonju, South Korea
4 Department of Internal Medicine, Uijeongbu St Mary,s Hospital College of Medicine, The Catholic University, Uijeongbu, South Korea
5 Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University Health System, Yonsei University College of Medicine, Seoul, Korea
6 Department of Internal Medicine, Department of Internal Medicine, Bundang CHA Medical Center, CHA University, Seongnam, Korea
7 Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea
8 Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea
9 Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea
10 Department of Internal Medicine, College of Medicine & Hospital, Catholic University of Daegu, Daegu, Korea
11 Department of Pathology, Wonju Severance Christian Hospital, Yonsei University, Wonju College of Medicine, Wonju, South Korea
12 Department of Pathology, Seoul St Mary's Hospital, College of Medicine, The Catholic University, Seoul, Korea
13 Phamicell Co., Ltd., Sungnam, Korea
14 Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University, Seoul, Korea

Authors share co-first and co-corresponding authorship
Authors share co-first and co-corresponding authorship

*Contact Information: Soon Koo Baik, M.D., Ph.D., Department of Internal Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju 26426, South Korea, Si Hyun Bae, M.D., Ph.D., Division of Hepatology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 137-041, South Korea

Abstract
Bone marrow-derived mesenchymal stem cell (BM-MSC) transplantation has been suggested as an effective therapy for liver cirrhosis. The efficacy and safety of autologous BM-MSC transplantation in the treatment of alcoholic cirrhosis (AC) were investigated. Seventy-two patients with baseline biopsy-proven AC who had been alcohol-abstinent for more than 6 months underwent a multicenter, randomized, open-label, phase 2 trial. Patients were randomly assigned to three groups: one control group and two autologous BM-MSC groups that underwent either one-time or two-time hepatic arterial injections of 5 × 107 BM-MSCs 30 days after bone marrow aspiration. A follow-up biopsy was performed 6 months after enrollment and adverse events were monitored for 12 months. The primary endpoint was the improvement in the fibrosis-quantification based on Picrosirius-red staining. The secondary endpoints included liver function tests, Child-Pugh score, and the Model for End-stage Liver Disease score. The outcomes were analyzed by per-protocol analysis. In terms of fibrosis-quantification (before vs. after), one-time and two-time BM-MSC groups were associated with 25% (19.5±9.5% vs. 14.5±7.1%) and 37% (21.1±8.9% vs. 13.2±6.7%) reductions in the proportion of collagen, respectively (P<0.001). In the inter-group comparison, two-time BM-MSC transplantation in comparison with one-time BM-MSC transplantation was not associated with improved results in fibrosis-quantification (P>0.05). The Child-Pugh scores of both BM-MSC groups (one-time: 7.6±1.0 vs. 6.3±1.3 and two-time: 7.8±1.2 vs. 6.8±1.6) were also significantly improved following BM-MSC transplantation (P<0.05). The proportion of patients with adverse events did not differ among the three groups. Conclusion: Autologous BM-MSC transplantation safely improved histologic fibrosis and liver function in patients with AC. This article is protected by copyright. All rights reserved.

Keywords: Bone Marrow; Mesenchymal Stem Cell; Cirrhosis; Alcohol; Transplantation

논문정보 F1000선정
- 형식: Research article
- 게재일: 2016년 06월 (BRIC 등록일 2016-06-27)
- 연구진: 국내연구진태극기
- 분야: Medicine
관련 보도자료
파미셀은 간경변 줄기세포치료제 '셀그램-엘씨(Cellgram-LC)의 임상2상 결과가 미국 간학회 공식학회지 '헤파톨로지(Hepatology)' 최근호에 게재됐다고 11일 밝혔다.
광유전학의 과거, 현재와 미래[Neuron]
김윤석
발표: 김윤석 (Stanford University)
일자: 2020년 7월 30일 (목) 오후 02시 (한국시간)
언어: 한국어
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