Zhang 2018.
| Study characteristics | ||
| Methods | Phase I randomised, controlled, open‐label, single‐centre (Shaanxi Provincial People’s Hospital in China) clinical trial. | |
| Participants | 82 participants (age >18‐70 years old) were included from June 2012 to June 2015. Inclusion criteria: patients were above 18 years of age, with moderate to severe CD (Crohn’s disease activity index [CDAI] between 220 and 450). All patients had received steroid maintenance therapy for more than 6 months before enrolment. Concomitant immunosuppressive agents (including azathioprine, 6‐mercaptopurine or methotrexate) were allowed but the dosage was maintained unless steroid was discontinued. Anti‐tumour necrosis factor (anti‐TNF) therapy was not allowed within 3 months prior to the selection. |
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| Interventions | Intervention group: 41 patients were randomly selected to receive a total of four peripheral intravenous infusions of 1×106 Expanded Umbilical Cord Mesenchymal Stem Cells UC‐MSCs/kg, with one infusion per week. UC‐MSCs were allogenic extracted from one donor (Umbilical cord of a newborn). Control group: received the associated immunosuppression only. |
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| Outcomes | Primary endpoint: patients were followed up for 12 months. CDAI, Harvey‐Bradshaw index (HBI), and corticosteroid dosage were assessed. | |
| Notes | For preoperative prophylaxis of thrombosis, 500 IU of low‐molecular‐weight heparin were administered by subcutaneous injection once a day, for a total of 3 days. Trial start date: June 2012 Trial ending date: June 2015 Trial registry number: NCT02445547 Funding Source: Sponsor: Fuzhou General Hospital. Collaborator: Shaanxi Provincial People's Hospital Conflict of interest: No potential conflict of interest relevant to this article was reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Computer‐generated block randomization was used to assign each participant to one of the study groups." |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label trial |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis was done. Reasons for withdrawal were clearly stated, “Four patients dropped out in the UC‐MSC group and three dropped out in the control group both due to non‐adherence.” |
| Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes match those in protocol |
| Other bias | Low risk | No differences in baseline characteristics |