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Stem Cell Fistula Plug in Post Surgical Leak Fistulas

NCT02807389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-04-23

No results posted yet for this study

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.

Conditions

  • Surgical Leak Fistula

Interventions

DRUG

MSC Fistula Plug

Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell.

Sponsors & Collaborators

Principal Investigators

  • William A Faubion, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2019-04-02
Completion
2019-04-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807389 on ClinicalTrials.gov