NCT02589119

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

A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With High, Transsphincteric Cryptoglandular Perianal Fistulas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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, 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.

Detailed description

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore\® Bio-A\® Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients (age \> 18 years) 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 as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. Study visits are Day 1, Week 2, Week 4, Week 8, Week 12, Week 24, Week 52, and Week 104. This is an autologous product derived from the patient and used only for the same patient.

Conditions

• Perianal Fistula
• Cryptoglandular 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 cell.

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2015-10-28
• Last updated: 2019-12-06

Locations

1 site across 1 country: United States