Background: Stem cell therapy (SCT) for the treatment of Crohn's disease (CD) is still in its infancy, whether SCT is associated with improved outcomes is unclear. We performed a meta-analysis to evaluate the efficacy and safety of patients receiving SCT.
Methods: Electronic database were searched for eligible studies. Raw data from included studies were pooled for effect estimates. The primary endpoint was clinical remission. Secondary outcomes included proportions of patients who were clinical response, endoscopic remission or fistula healing. Subgroup analyses were performed for exploration of heterogeneity regarding all outcomes.
Results: We analyzed 36 studies comprising 588 patients with active CD. A random-effects meta-analysis of studies of SCT as systemic infusion showed 63% (95% CI, 48%–76%, n=182) of patients achieved clinical remission. Similarly, a random-effects pooled rate of clinical response and endoscopic remission were 62% (95% CI 41%–80%, n=164) and 30% (95% CI 14%–54%, n=66), respectively. A random-effects meta-analysis of all perianal CD studies showed that 57% (95% CI, 45%–67%, n=271) of patients had healed fistula with SCT. The pooled rate of clinical recurrence was high of 23% (95% CI 16–31, n=216) with a follow-up >12 months. The pooled rate of severe adverse events (SAEs) and SAEs related to SCT were 14% (95% CI 8%–22%) and 10% (95% CI 5%-18%, n=427), respectively. A funnel plot and Egger's test suggested no existence of publication bias.
Conclusions: SCT was associated with improved clinical and endoscopic remission or response, as well as fistula healing. SCT is therefore emerging as an alternative treatment for active CD.