NCT03209700

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: William A. Faubion, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Perianal Fistula
• Cryptoglandular Perianal Fistula
• Crohn's Perianal Fistula

Interventions

Type	Name	Description
DRUG	MSC-AFP	Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cells.

Timeline

• Start date: 2017-07-20
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2017-07-06
• Last updated: 2020-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study