This is a prospective, single-arm, open study to evaluate the efficacy and safety of human umbilical cord MSCs in the treatment of refractory moderate-to-severe Crohn's disease. The study will be conducted as follows: a total of 40 patients will be recruited and will receive either MSC injection into the diseased intestinal mucosa or intravenous MSC injection + MSC injection into the diseased intestinal mucosa. The proportion of patients with clinical and endoscopic response or remission will be used as the primary evaluation for follow-up. The Crohn's disease activity index (CDAI) was used to assess the severity of CD disease, with CDAI <150 considered to be in clinical remission; a decrease in CDAI ≥70 was considered to be clinically effective, also referred to as clinical response. Endoscopic response was defined as at least 50% improvement in the simplified endoscopic score for Crohn's disease (SES-CD) from baseline, and endoscopic remission was defined as a SES-CD score ≤2.
This is a prospective, single-arm, open-ended study to evaluate the efficacy and safety of human umbilical cord MSCs in the treatment of refractory moderate-to-severe Crohn's disease. The study protocol is either MSC injection into the patient's diseased intestinal mucosa or intravenous MSC injection + MSC injection into the patient's diseased intestinal mucosa. Follow-up time points were pre-treatment (week 0), week 4, week 8, week 12, and week 24 post-treatment, and the primary evaluation at follow-up was the number of subjects with clinical and endoscopic response or remission.