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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Patients will have a mesenchymal stromal cell coated anal fistula plug placed in their Crohn's perianal fistula tract.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Number of participants with treatment-related adverse events (safety and toxicity)
Participants will have a health assessment and blood work done at each study visit to monitor for adverse events.
Time frame: 2 months to approximately at 24 months
Number of participants with response to the treatment regarding cessation of drainage from the treated fistula.
Participants will have a clinical assessment of fistula drainage at each study visit.
Time frame: 2 months to approximately at 24 months
Number of participants with radiographic response to the treatment regarding the treated fistula.
Participants will have an assessment of healing radiographically by magnetic resonance imaging (MRI) at Week 2 visit, Week 8, and Week 24.
Time frame: Week 2, Week 8, and Week 24
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