Stem Cell Fistula Plug in Post Surgical Leak Fistulas

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.

Timeline

Start

2017-03-14

Primary completion

2019-04-02

Completion

2019-04-02

Drugs

Indications