In patients with Crohn’s disease (CD), perianal fistulas frequently recur, causing substantial morbidity. We performed a 12 patient, 6 month phase I trial to determine whether autologous mesenchymal stem cells (MSCs), applied in a bioabsorbable matrix, can heal the fistula. Fistula repair was not associated with any serious adverse events related to MSCs or plug placement. At 6 months, 10/12 patients (83%) had complete clinical healing and radiographic markers of response. We found placement of MSC-coated matrix fistula plugs in 12 patients with chronic perianal fistulas to be safe and lead to clinical healing and radiographic response in 10 patients.
Earn Continuing Education (CME) credit online at cme.lww.com. This activity has been approved for AMA PRA Category 1 credit. TM Funding/Support: None reported.
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.
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