Stem Cell Fistula Plug in Post Surgical Leak Fistulas
Status:
Completed
Trial end date:
2019-04-02
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 (age 18 and greater) with persistent symptomatic
post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic
therapies will be enrolled. The subjects will be subsequently followed for fistula response
and closure for 18 months. This is an autologous product derived from the patient and used
only for the same patient.