Stem Cell Fistula Plug in Perianal Crohn's Disease
Status:
Completed
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
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. Twenty adult patients (age 18 years or older) with refractory, complicated
perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard
adjuvant therapy including drainage of infection and placement of a draining seton with
continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining
seton, the seton will be replaced with the MSC loaded Gore® Bio-A® 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.