Autologous Mesenchymal Stem Cells, Applied in a Bioabsorbable Matrix, for Treatment of Perianal Fistulas in Patients With Crohn's Disease

Abstract

In patients with Crohn's disease, perianal fistulas recur frequently, causing substantial morbidity. We performed a 12-patient, 6-month, phase 1 trial to determine whether autologous mesenchymal stem cells, applied in a bioabsorbable matrix, can heal the fistula. Fistula repair was not associated with any serious adverse events related to mesenchymal stem cells or plug placement. At 6 months, 10 of 12 patients (83%) had complete clinical healing and radiographic markers of response. We found placement of mesenchymal stem cell-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. ClinicalTrials.gov Identifier: NCT01915927.

Keywords: Cell Therapy; Clinical Trial; IBD; STOMP Trial.

Conflict of interest statement

DISCLOSURES: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Allan Dietz and Greg Butler are inventors of technology used as a tool in this research; the technology has been licensed to a commercial entity (PLTMax; Mill Creek LifeScienes). ABD and Mayo Clinic have equity in the company and ABD and GWB have contractual rights to receive royalties from the licensing of this technology. ABD has governance responsibilities within this company. These conflicts have been disclosed to and are managed by the Mayo Clinic Conflict of Interest Board and are included here as directed by them. No other authors have a conflict to report.

Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1. Fistula response upon treatment with MSC-MATRIX

(A) Pre and post treatment imaging in a representative patient. Red arrow indicates intersphincteric fistula in 39 year-old female Crohn’s patient prior to treatment and six months after therapy, along with images from perianal examination at time of plug placement (top row) and follow-up MRI. (B) Cumulative results of the changes in Van Aasche score, tract length and fistula diameter. P values represent paired T test before and six months after plug placement. For the fistula diameter, the P value on the upper is representative of all samples while the P value below is for the 11 samples with a starting diameter less than 20 mm.