Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial

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 1x10(6) 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 +/- 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. Conclusions: UC-MSCs were effective in the treatment of CD and produced mild side effects.