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Adipose Derived SVF for Aero-digestive Fistulae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03792360
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : October 15, 2019
Information provided by (Responsible Party):
Timothy Woodward, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Tracheoesophageal Fistula Bronchoesophageal Fistula Tracheal Fistula Drug: SVF (Stromal Vascular Fraction) Phase 1

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 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study: Evaluating the Safety and Feasibility of Using Autologous Adipose-Derived Stromal Vascular Fraction (SVF) for the Treatment of Aerodigestive Fistulae in Adults
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 4, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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.

Primary Outcome Measures :
  1. Safety, feasibility and adverse events [ Time Frame: 5 years ]
    Effectiveness and safety of stromal cell therapy in the closure of aero digestive fistula

Secondary Outcome Measures :
  1. Fistula Closure [ Time Frame: 5 years ]
    Efficacy of fistula therapy as determined by size reduction and/or closure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults ≥ 18 years old
  • Adults ≤ 90 years old
  • Aerodigestive fistula 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
  • A prior diagnosis of ADF in which the standard therapy has failed or is not applicable
  • Fistula location may include:

    • Tracheopharyngeal
    • Tracheoesophageal
    • Bronchoesophageal
  • 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 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, this will be excluded.Patients that require surgical intervention at the fistula 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
  • Drug or alcohol dependence
  • Active infectious disease positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis
  • End of life

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03792360

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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Timothy A Woodward Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Timothy Woodward, Mayo Clinic:
Informed Consent Form  [PDF] September 27, 2018

Additional Information:
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Responsible Party: Timothy Woodward, Principal Investigator, Mayo Clinic Identifier: NCT03792360     History of Changes
Other Study ID Numbers: 17-003774
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Digestive System Fistula
Digestive System Diseases
Tracheoesophageal Fistula
Pathological Conditions, Anatomical
Esophageal Fistula
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Fistula
Respiratory Tract Diseases
Tracheal Diseases