The Second Department of Gastroenterology, Shaanxi Provincial People's Hospital, Xi'an, China.
Department of Infectious Diseases, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, China.
Gut Liver. 2018 Jan 15;12(1):73-78. doi: 10.5009/gnl17035.
BACKGROUND/AIMS: Stem cell therapy has been applied to treat a variety of autoimmune diseases, including Crohn's disease (CD), but few studies have examined the use of umbilical cord mesenchymal stem cells (UC-MSCs). This trial sought to investigate the efficacy and safety of UC-MSCs for the treatment of CD.
Eighty-two patients who had been diagnosed with CD and had received steroid maintenance therapy for more than 6 months were included in this study. Forty-one patients were randomly selected to receive a total of four peripheral intravenous infusions of 1×10 UC-MSCs/kg, with one infusion per week. Patients were followed up for 12 months. The Crohn's disease activity index (CDAI), Harvey-Bradshaw index (HBI), and corticosteroid dosage were assessed.
Twelve months after treatment, the CDAI, HBI, and corticosteroid dosage had decreased by 62.5±23.2, 3.4±1.2, and 4.2±0.84 mg/day, respectively, in the UC-MSC group and by 23.6±12.4, 1.2±0.58, and 1.2±0.35 mg/day, respectively, in the control group (p＜0.01, p＜0.05, and p＜0.05 for UC-MSC vs control, respectively). Four patients developed a fever after cell infusion. No serious adverse events were observed.
UC-MSCs were effective in the treatment of CD and produced mild side effects.
背景/目的：干细胞疗法已被应用于治疗多种自身免疫性疾病，包括克罗恩病（CD），但很少有研究检查过脐带间充质干细胞（UC-MSCs）的用途。本试验旨在研究 UC-MSCs 治疗 CD 的疗效和安全性。
本研究纳入了 82 例已被诊断为 CD 并接受类固醇维持治疗超过 6 个月的患者。随机选择 41 例患者接受总共 4 次外周静脉输注 1×10 UC-MSCs/kg，每周输注 1 次。对患者进行 12 个月的随访。评估克罗恩病活动指数（CDAI）、Harvey-Bradshaw 指数（HBI）和皮质类固醇剂量。
治疗 12 个月后，UC-MSC 组的 CDAI、HBI 和皮质类固醇剂量分别降低了 62.5±23.2、3.4±1.2 和 4.2±0.84mg/天，对照组分别降低了 23.6±12.4、1.2±0.58 和 1.2±0.35mg/天（p＜0.01、p＜0.05 和 p＜0.05 分别为 UC-MSC 与对照组相比）。4 例患者在细胞输注后出现发热。未观察到严重不良事件。
UC-MSCs 对 CD 有效，且产生轻度副作用。
