Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)
Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
Participant gender:
Summary
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer
using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of 20
million cells. 15 adult patients, ages 18 years and older with cryptoglandular 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; 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.