Abstract

Perianal fistulizing Crohn’s disease (PFCD) is associated with significant morbidity and might negatively impact the quality of life of CD patients. In the last two decades, the management of PFCD has evolved in terms of the multidisciplinary approach involving gastroenterologists and colorectal surgeons. However, the highest fistula healing rates, even combining surgical and anti-TNF agents, reaches 50% of treated patients. More recently, the administration of mesenchymal stem cells (MSCs) have shown notable promising results in the treatment of PFCD. The aim of this review is to describe the rationale and the possible mechanism of action of MSC application for PFCD and the most recent results of randomized clinical trials. Furthermore, the unmet needs of the current administration process and the expected next steps to improve the outcomes will be addressed.

Highlights

  • Crohn’s disease (CD) is a chronic inflammatory disease of the gastrointestinal tract of unknown etiology, which continues to increase in incidence for unknown reasons, resulting in a significant burden to the healthcare system [1,2]

  • Indications for the use of mesenchymal stem cells (MSCs) in perianal CD are mostly concentrated in fistulas

  • The product is indicated for treatment of complex perianal fistulas in adult patients with nonactive/mildly active luminal CD, when fistulas have shown an inadequate response to at least one conventional or biologic therapy [62,63]

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Summary

Introduction

Crohn’s disease (CD) is a chronic inflammatory disease of the gastrointestinal tract of unknown etiology, which continues to increase in incidence for unknown reasons, resulting in a significant burden to the healthcare system [1,2]. The same group pioneered the first phase I trial in 2005 [16] In this trial, addressing safety and feasibility of the procedure, five patients with perianal Crohn’s disease were initially treated with autologous stem cell injection along the perianal fistula. These promising results generated a wave of phase I [17,18,19,20,21] and phase II [22,23] to study the safety and efficacy of using MSCs to treat perianal CD. Despite the heterogeneity in protocols using allogeneic [17,19,21,22] or autologous

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