Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae

April 4, 2023 updated by: Bhaumik Brahmbhatt, Mayo Clinic

A Pilot Study: Evaluating the Safety and Feasibility of Using Autologous Adipose-Derived Stromal Vascular Fraction (SVF) for the Treatment of Aerodigestive & Enterocutaneous Fistulae in Adults

Determine safety and feasibility of using institutionally prepared autologous, uncultured SVF on patients with aerodigestive and enterocutaneous fistulae secondary to malignancy, trauma or surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this pilot study is to evaluate the feasibility, time, cost, safety, limitations, and efficacy of the use of institutionally processed SVF for management and closure of aero-digestive and enterocutaneous fistulae. This pilot study would help identify design issues and the potential success of fistulae closure by the means of autologous SVF administration before a full-scale trial is performed.

A secondary aim is the closure of aero-digestive and enterocutaneous fistulae along with characteristics such as size, etiology, recurrence, localization, and the association of these factors withoutcome after SVF administration. The SVF quantification, characterization and differentiation in vitro will be described.

This process will help identify the type of fistulae that are susceptible to closure with human cell therapy.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ≥ 18 years old
  • Adults ≤ 90 years old
  • Fistula or sinus tract opening size between 2 mm and 15 mm in diameter (as measured by comparing its size with the open mouth of a biopsy forceps)
  • Inpatient or outpatient setting
  • Recurrent or de novo fistulas or sinus tracts
  • A prior diagnosis of ADF OR ECF in which the standard therapy has failed or is not applicable
  • Fistula or sinus tract location may include:
  • Tracheopharyngeal
  • Tracheoesophageal
  • Bronchoesophageal
  • Gastric, duodenal, jejunal, ileal, colonic or anastomotic -communicating to the skin (cutaneous)
  • Esophogealgastric anastomosis
  • Mediastinal anastomotic leak
  • Fistula etiology may include:
  • Secondary to previous malignancy with complete remission
  • Secondary to radiotherapy as long as complete remission for 5 years has been achieved and documented
  • Congenital with or without previous treatment
  • Secondary to surgical interventions or endoscopic therapies such as dilation and esophageal manipulation
  • Post prolonged tracheal intubation
  • Secondary to inflammatory bowel disease
  • Secondary to foreign body ingestion
  • Secondary to thoracic trauma/crush injuries
  • Secondary to caustic ingestion
  • Secondary to pneumonectomy or mechanical ventilation
  • Esophagomalacia
  • The ability of subjects to give appropriate consent or have an appropriate representative available to do so
  • The ability of subjects to return for follow up endoscopic assessment as established.

Exclusion Criteria

  • Exposure to any investigational drug or procedure within 3 months prior to study entry.
  • Patients with allergy to fibrin glue (TISSEEL) or anesthetics
  • Patients with active/ongoing malignancy such as esophageal, lung, tracheal, thyroid, oropharyngeal or gastric cancer
  • Patients on active regimen of chemotherapy
  • Patients receiving radiation
  • Diabetics with poor glucose metabolic control exhibited by an HbA1c > 9
  • If there is evidence, in endoscopy, of dysplastic-appearing mucosa such as Barrett's dysplasia near the fistula or sinus tracts, this will be excluded. Patients that require surgical intervention at the fistula or sinus tract area for any reason
  • BMI of <16 (may difficult lipoaspiration procedure)
  • Women who are pregnant or nursing or women of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • Clinical signs of respiratory tract or pleuro-pulmonary infections
  • Prolonged (> 6 months) use of steroids
  • Patients with fistulae or sinus tracts >15mm
  • Drug or alcohol dependence
  • Active infectious disease positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis
  • End of life

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: SVF (Stromal Vascular Fraction)
The stromal vascular fraction (SVF), isolated when fresh lipoaspirates are enzymatically digested with a collagenase, contains a heterogeneous cellular and extracellular milieu. SVF is an aqueous fraction, consisting of endothelial cells and their precursors, macrophages, smooth muscle cells, lymphocytes, pericytes, pre-adipocytes and actual AMSCs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Adverse Events from a single dose of autologous stromal vascular fraction (SVF) applied endoscopically into aerodigestive fistulae or enterocutaneous fistula [Safety and Tolerability].
Time Frame: 5 Years
Documentation of signs of adverse reactions from intravascular application of TISEEL, including: intravascular coagulation, thromboembolic events and acute hypersensitivity reactions. Documentation of signs of increased fistula size and/or aggravation of symptoms associated with fistulous tract, including: paroxysmal cough, dysphagia, wheezing, abdominal distention, chest pain, dyspnea, pneumonia.
5 Years
Assessment of Adverse Events from liposuction procedure [Safety and Tolerability].
Time Frame: 5 Years
Signs of adverse reactions to the lipoaspiration procedure, including: allergic reaction to Hunstad solution, infection at the puncture wound site or risk of bleeding at the puncture wound site.
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to improve the success of surgical repair by fistulous tract reduction and/or closure.
Time Frame: 16 weeks
Measurement and photography of the fistula in endoscopic/bronchoscopic evaluation.
16 weeks
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to improve the success of surgical repair in reducing cardinal symptoms.
Time Frame: 5 Years
Documentation of reduction of cardinal symptoms by history and physical examination.
5 Years
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to prevent recurrence of aerodigestive fistulae or enterocutaneous fistulae.
Time Frame: 5 Years
Documentation of fistula recurrence by long term follow-up.
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Bhaumik Brahmbhatt, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

February 1, 2027

Study Completion (Anticipated)

February 1, 2028

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-003774

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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