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. 20 patients (age 12 to 17 years) with Crohns 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.