A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease.
Overview
- Phase
- Phase 1
- Intervention
- MSC-AFP
- Conditions
- Perianal Crohn's Disease
- Sponsor
- William A. Faubion, M.D.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- To determine the safety and toxicity of using autologous MSC coated fistula plug in patients with fistulizing Crohn's Disease.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore® Bio-A® 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.
Investigators
William A. Faubion, M.D.
PI
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Only 1 arm: treatment with MSC-AFP
Intervention: MSC-AFP
Outcomes
Primary Outcomes
To determine the safety and toxicity of using autologous MSC coated fistula plug in patients with fistulizing Crohn's Disease.
Time Frame: 2-24 months
The primary endpoint of this study is to determine the safety and feasibility of using adipose derived, autologous mesenchymal stromal cells (MSC) bound to the Gore® Bio-A® Fistula Plug for treatment of refractory CD perianal fistulae.
Secondary Outcomes
- To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC(2-24 months)