Surgical Leak Fistula Clinical Trial
Official title:
A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Complicated Post-surgical Fistulas
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.
Visit 1: Patients will be evaluated for eligibility (inclusion/exclusion checklist) and
written, informed consent will be obtained. Patients will undergo general exam with vital
signs. Patients will be scheduled for a fat biopsy to collect the tissue needed to grow MSC.
In the event there is no cell growth from the tissue obtained from the first biopsy, one
further attempt will made from a second tissue sample from this patient. However, if the
second attempt fails to grow cells, no further attempts will be made, and the subject will
not continue in the study.
Visit 2 (Week 0; Day 0): Patients will undergo an interventional endoscopy, the fistula tract
will be assessed and the stem cell coated will be placed endoscopically.
Study visit will be as follows:
Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8;
Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (week 52; Month 12)
Visit 10 (Week 78; Month 18)
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