Stem Cell Fistula Plug in Post Surgical Leak Fistulas

Phase 1

Completed

• Conditions: Surgical Leak Fistula
• Interventions: Drug: MSC Fistula Plug

• Registration Number: NCT02807389
• Lead Sponsor: Mayo Clinic

Brief 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 (age 18 and greater) with persistent symptomatic post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic therapies will be enrolled. The subjects will be subsequently followed for fistula response and closure for 18 months. This is an autologous product derived from the patient and used only for the same patient.

Detailed Description

Visit 1: Patients will be evaluated for eligibility (inclusion/exclusion checklist) and written, informed consent will be obtained. Patients will undergo general exam with vital signs. Patients will be scheduled for a fat biopsy to collect the tissue needed to grow MSC. In the event there is no cell growth from the tissue obtained from the first biopsy, one further attempt will made from a second tissue sample from this patient. However, if the second attempt fails to grow cells, no further attempts will be made, and the subject will not continue in the study.

Visit 2 (Week 0; Day 0): Patients will undergo an interventional endoscopy, the fistula tract will be assessed and the stem cell coated will be placed endoscopically.

Study visit will be as follows:

Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (week 52; Month 12) Visit 10 (Week 78; Month 18)

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Study Start: 2017-03-14
• Status Verified: 2019-04
• Primary Completion: 2019-04-02
• Study Completion: 2019-04-02
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSC Fistula plug: Single Treatment Group	MSC Fistula Plug	All patients received treatment of a stem cell coated fistula plug.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	2-18 months	Data collection will include: worsening of the fistula, abnormal laboratory values, or significant abnormalities in physical examination. The Outcome Measure will be the number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of Fistula Closure	2-18 months	Data collection will include: degree of drainage cessation from fistula. The Outcome Measure will be the number of Participants With Closure of their Fistula.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States