Long-Term Results of Adipose-Derived Stem Cell Therapy for the Treatment of Crohn's Fistula
Long-Term Results of Adipose-Derived Stem Cell Therapy for the Treatment of Crohn's Fistula
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DOI：
10.5966/sctm.2014-0199
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发表时间：
2015-05-01
影响因子：
6
通讯作者：
Yu, Chang Sik
中科院分区：
文献类型：
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作者：
Cho, Yong Beom;Park, Kyu Joo;Yu, Chang Sik
之前的脂肪干细胞(ASC)治疗克罗恩病相关瘘管的第二阶段临床试验证明了安全性和治疗潜力，可持续1年。在目前的研究中，43名II期试验患者中的41名被随访了一年，无论最初一年的反应如何。术后24个月，改良方案分析26例中21例(80.8%)完全愈合，改良意向分析36例中27例(75.0%)完全愈合。未观察到与ASC给药相关的不良事件。此外，最初治疗后完全闭合的情况持续良好。这些结果有力地表明，自体ASCs可能是治疗克罗恩瘘的一种新的选择。
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.