Stem Cell Fistula Plug in Perianal Crohn's Disease

Phase 1

Completed

• Conditions: Perianal Crohn's Disease
• Interventions: Drug: MSC-AFP

• Registration Number: NCT01915927
• Lead Sponsor: William A. Faubion, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-05
• Status Verified: 2019-12
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-31
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MSC-AFP	Only 1 arm: treatment with MSC-AFP

Primary Outcome Measures

Name	Time	Method
To determine the safety and toxicity of using autologous MSC coated fistula plug in patients with fistulizing Crohn's Disease.	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 Outcome Measures

Name	Time	Method
To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC	2-24 months	To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC i) Clinically by drainage assessment and ii) Radiographically by MRI, the gold standard test for assessment of healing.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States