Pediatric MSC-AFP Sub-study for Crohn's Fistula

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the patient.

Clinical Trial Description

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells. 5 patients (age 12 to 17 years) with Crohn's perianal fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03449069
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	Phase 1
Start date	July 23, 2018
Completion date	December 31, 2023

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