Efficacy and safety of stem cell therapy for Crohn's disease: a meta-analysis of randomized controlled trials.

PURPOSE: Small-scale clinical trials have provided evidence suggesting the effectiveness of stem-cell therapy (SCT) for patients diagnosed with Crohn's disease (CD). The objective of the research was to systematically assess the effectiveness and safety of SCT for individuals diagnosed with CD through a comprehensive review and meta-analysis.

METHODS: A search was conducted in Medline (PubMed), CENTER (Cochrane Library), and Embase (Ovid) to find randomized controlled trials (RCTs) that assessed the impact of SCT on the occurrence of clinical remission (CR) and severe adverse events (SAE) among patients diagnosed with CD. The Cochrane Q test and estimation of I2 were used to assess heterogeneity among studies. After incorporating heterogeneity, a random-effects model was employed for data pooling.

RESULTS: Overall, 12 RCTs involving 632 adult patients with medically refractory CD or CD-related fistula were included. In comparison with placebo or no treatment, SCT showed a greater likelihood of CR (odds ratio [OR] 2.08, 95% CI 1.39-3.12, p < 0.001) without any notable heterogeneity (I2  = 0%). Consistent results were observed in subgroup analyses based on study design, patient diagnosis, source and type of stem cells, and follow-up durations, with all p-values for subgroup analyses being greater than 0.05. The occurrence of SAE was similar among patients assigned to SCT and the placebo/no treatment cohorts (OR 0.70, 95% CI 0.37-1.33, p = 0.28; I2  = 0%).

CONCLUSIONS: For patients with medically refractory CD or CD-related fistula, SCT may be an alternatively effective and safe treatment.