Systematic review with meta-analysis: Safety and efficacy of local injections of mesenchymal stem cells in perianal fistulas

Rachele Ciccocioppo, Catherine Klersy, Daniel A. Leffler, Raquel Rogers, Dimitri Bennett, Gino Roberto Corazza

Research output: Contribution to journalReview articlepeer-review


Perianal fistulas in Crohn's disease (CD) represent a highly debilitating and difficult-to-treat condition. Given emerging supportive evidence, we conducted a systematic review and meta-analysis of all trials/observational studies to establish the safety and efficacy of local injections of mesenchymal stem cells (MSCs). The PRISMA-P statement was applied for planning and reporting, and MEDLINE, EMBASE, Web of Science, Cochrane, CINAHL, database, and ECCO 2017 proceedings were searched for published observational studies and one-arm and randomized clinical trials (RCTs). Safety was assessed in terms of acute local/systemic events, long-term events, and relatedness with MSC treatment. Efficacy was evaluated in terms of external and/or radiological closure of fistula tracks. After a review of 211 citations, 23 studies, including 696 participants, were evaluated. Four were RCTs with a total of 483 patients. Overall, fistula closure occurred in 80% of MSC-treated patients. In RCTs, this rate was 64% in the MSC arm and 37% in the control arm (relative risk (RR) = 1.54). Radiological response occurred in 83% of MSC-treated patients. Treatment-related adverse events occurred in 1% of MSC-treated patients, with severe treatment-related adverse events reaching 0% over a median follow-up of 6 months. In RCTs, treatment-related adverse events occurred in 13% in the MSC arm and 24% in the control arm (RR = 0.65). The relapse rate was 0. These results suggest that a local MSC injection is safe and efficacious. Further clinical trials with standardized end-points are required to ensure the timely implementation of this new therapy in the management of perianal CD.

Original languageEnglish
Pages (from-to)249-260
Number of pages12
JournalJGH Open
Issue number3
Publication statusPublished - Jun 1 2019


  • Crohn's disease fistulas
  • cryptoglandular fistulas
  • efficacy
  • mesenchymal stem cells
  • safety

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology


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