Cho Yong Beom, Park Kyu Joo, Yoon Sang Nam, Song Kee Ho, Kim Do Sun, Jung Sang Hun, Kim Mihyung, Jeong Hee Young, Yu Chang Sik
Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; Department of Surgery, Seoul National University College of Medicine, Seoul, Korea; Department of Colon & Rectal Surgery, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea; Department of Surgery, Daehang Hospital, Seoul, Korea; Department of Surgery, Yeungnam University Medical Center, Daegu, Korea; Anterogen Co., Ltd., Seoul, Korea.
Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; Department of Surgery, Seoul National University College of Medicine, Seoul, Korea; Department of Colon & Rectal Surgery, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea; Department of Surgery, Daehang Hospital, Seoul, Korea; Department of Surgery, Yeungnam University Medical Center, Daegu, Korea; Anterogen Co., Ltd., Seoul, Korea
Stem Cells Transl Med. 2015 May;4(5):532-7. doi: 10.5966/sctm.2014-0199. Epub 2015 Mar 31.
A previous phase II clinical trial of adipose-derived stem cell (ASC) therapy for fistulae associated with Crohn's disease, a devastating condition with a high recurrence rate, demonstrated safety and therapeutic potential with a 1-year sustained response. In the present study, 41 of the 43 phase II trial patients were followed for an additional year, regardless of response in the initial year. At 24 months, complete healing was observed in 21 of 26 patients (80.8%) in modified per protocol analysis and 27 of 36 patients (75.0%) in modified intention-to-treat analysis. No adverse events related to ASC administration were observed. Furthermore, complete closure after initial treatment was well-sustained. These results strongly suggest that autologous ASCs may be a novel treatment option for Crohn's fistulae.
一项先前针对与克罗恩病相关瘘管的脂肪来源干细胞（ASC）疗法的II期临床试验表明，该疗法具有安全性和治疗潜力，能带来为期1年的持续缓解效果。克罗恩病是一种破坏性疾病，复发率很高。在本研究中，II期试验的43名患者中有41名被额外随访了一年，无论其在第一年的反应如何。在24个月时，改良的符合方案分析中，26名患者中有21名（80.8%）实现完全愈合；改良的意向性分析中，36名患者中有27名（75.0%）实现完全愈合。未观察到与ASC给药相关的不良事件。此外，初始治疗后的完全闭合情况维持良好。这些结果有力地表明，自体ASC可能是克罗恩病瘘管的一种新型治疗选择。
