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Cryptoglandular Perianal Fistula clinical trials

View clinical trials related to Cryptoglandular Perianal Fistula.

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NCT ID: NCT03209700 Completed - Perianal Fistula Clinical Trials

Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas

MSC-AFP
Start date: July 20, 2017
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT02589119 Completed - Perianal Fistula Clinical Trials

Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)

Start date: January 2016
Phase: Phase 1
Study type: Interventional

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, ages 18 years and older with cryptoglandular fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore Fistula Plug; 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.