Perianal Fistula Clinical Trial
Official title:
Re-treatment for Partial or Non-responders for a Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Perianal Fistulas
This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and 15-003200 (cryptoglandular perianal fistulas).
This study is an extension to re-treat partial and non-responders from the previously
approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and
15-003200 (cryptoglandular perianal fistulas). This study will enroll patients that have
persistent symptomatic perianal disease despite being treated with an MSC coated fistula
plug, and also treat patients that have had recurrence of their perianal fistula.
As per the previously approval treatment under IND 15356, patients will have a single
affected fistula treated, which is the same fistula that was treated in the original
protocol. The matrix for delivering the cells is a Gore Bio-A Fistula Plug.
Subjects will be screened at outpatient clinic visits and interested qualified subjects will
be offered participation in the trial and consented. At the first study visit (Visit 1;
Screening visit), the patient will be evaluated and assessment will be made if an EUA is
clinically necessary to assess the fistula. As this is a re-treatment trial, patients with
incomplete response to initial plug placement typically have close follow up, recent MRI
imaging, and may have a seton in place. If an EUA is clinically indicated, this would be by a
colorectal surgeon for drainage of sepsis and placement of a seton as part of the standard
clinical care for perianal fistula.
Patients will return on: Day 1, Week 4, Week 12, and Week 24.
;
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|---|---|---|---|
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