KMID : 1188320180120010073
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Gut and Liver 2018 Volume.12 No. 1 p.73 ~ p.78
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Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn¡¯s Disease: A Randomized Controlled Clinical Trial
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Zhang Jian
Lv Sa Mei Shi Li Ping Liu Xiao Jing Song Bin
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Abstract
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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.
Methods: 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¡¿106 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.
Results: Twelve months after treatment, the CDAI, HBI, and corticosteroid dosage had decreased by 62.5¡¾23.2, 3.4¡¾1.2, and 4.2¡¾0.84 mg/day, respectively, in the UC-MSC group and by 23.6¡¾12.4, 1.2¡¾0.58, and 1.2¡¾0.35 mg/day, respectively, in the control group (p£¼0.01, p£¼0.05, and p£¼0.05 for UC-MSC vs control, respectively). Four patients developed a fever after cell infusion. No serious adverse events were observed.
Conclusions: UC-MSCs were effective in the treatment of CD and produced mild side effects.
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KEYWORD
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Umbilical cord, Mesenchymal stromal cells, Crohn disease, Cellular therapy, Autoimmune
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