NCT03449069

Pediatric MSC-AFP Sub-study for Crohn's Fistula

A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the 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. 5 patients (age 12 to 17 years) with Crohn's perianal 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. This is an autologous product derived from the patient and used only for the same patient.

Conditions

• Fistula in Ano
• Crohn Disease

Interventions

Type	Name	Description
DRUG	MSC-AFP	Patients will have a mesenchymal stromal cell coated anal fistula plug placed in their Crohn's perianal fistula tract.

Timeline

• Start date: 2018-07-23
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-02-28
• Last updated: 2024-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study