First clinical case report of local microinjection of autologous fat and adipose-derived stromal vascular fraction for perianal fistula in Crohn\u2019s disease

Mélanie Serrero,Fanny Grimaud,Jean-Charles Grimaud,Cécile Philandrianos,Guy Magalon,Julie Véran,Mélanie Velier,Pierre Orsoni,Florence Sabatier,Pauline Francois,Jérémy Magalon,Carine Visée,Ariadne Desjeux

doi:10.1186/s13287-017-0736-6

Abstract

Mesenchymal stem cell therapy is a promising treatment for perianal Crohn’s fistulas refractory to conventional therapy, which are an extremely morbid complication and a true therapeutic challenge. Autologous adipose-derived stromal vascular fraction (ADSVF) is an easily accessible source of cells with angiogenic, anti-inflammatory, immunomodulatory, and regenerative properties. Here, we describe a case involving a patient with severe perianal Crohn’s fistulas refractory to the best medical and surgical practices who received local treatment with ADSVF and microfat. This patient was first examined under anesthesia with drainage via seton placement; 1 week later, on a single day, he underwent adipose tissue extraction, ADSVF and microfat preparation, and the local injection of 14 ml of microfat and approximately 20 million viable ADSVF cells into the soft tissue around the fistulas. No serious adverse events were observed. At the first endpoint at 12 weeks, the fistula had clinically healed with complete re-epithelialization of all external openings; no fistula tract was detected on magnetic resonance imaging, confirming this finding. This good clinical outcome was sustained at 48 weeks and was associated with a reduction in the severity of perianal disease and an improvement in quality of life. The current case highlights the therapeutic potential of a new cellular treatment for Crohn’s patients with refractory perianal fistulas based on the innovative hypothesis that the combined action of ADSVF in association with the trophic characteristics of a microfat graft could be beneficial for this condition.Trial registration: EudraCT number 201325, NCT02520843. Registered on 5 August 2015

Highlights

Crohn's disease is a transmural chronic inflammation that can affect any part of the digestive tract, ranging “from the mouth to the anus”
Philandrianos et al Stem Cell Research & Therapy (2018) 9:4 obtained approval from the appropriate French regulatory agency and ethics committee for our proposal to deliver a combined microfat and adiposederived stromal vascular fraction (ADSVF) treatment to ten patients who presented with recurrent perianal fistulas in the context of Crohn’s disease (NCT 02520843)
Patient After providing written informed consent, a 34-year-old man was included in the ADICROHN prospective phase I clinical trial (EudraCT number: 201325) registered at clinicaltrials.gov. He had presented with a complex perianal fistula associated with Crohn’s disease that was objectively assessed via a clinical examination under general anesthesia and magnetic resonance imaging (MRI) in accordance with recognized clinical, endoscopic, and histological criteria

Summary

Introduction

Crohn's disease is a transmural chronic inflammation that can affect any part of the digestive tract, ranging “from the mouth to the anus”. Perianal fistulas are frequent, occurring in almost one-third of Crohn’s patients, and the incidence of this condition is increasing [1]. The various problems induced by fistulas, such as pain, purulent discharge, abscess formation, and Philandrianos et al Stem Cell Research & Therapy (2018) 9:4 obtained approval from the appropriate French regulatory agency and ethics committee for our proposal to deliver a combined microfat and ADSVF treatment to ten patients who presented with recurrent perianal fistulas in the context of Crohn’s disease (NCT 02520843). We present the first case of a patient who reached the 48-week follow-up time point

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Conclusion