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WithdrawnNCT03792360Updated Apr 6, 2023

Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae

A Phase 1 interventional study of SVF (Stromal Vascular Fraction) in Tracheoesopharyngeal Fistula, Bronchoesophageal Fistula and Tracheoesophageal Fistula, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Study closed due to lack of patient enrollment.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Tracheoesopharyngeal Fistula
  • Bronchoesophageal Fistula
  • Tracheoesophageal Fistula
03

In context

Intestinal Fistula

20 studies on the registry are indexed under Intestinal Fistula; 2 are open to participants now.

Browse Intestinal Fistula studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Single Arm

    Drug: SVF (Stromal Vascular Fraction)

Interventions

  • DrugSVF (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.

06

What researchers measure

Primary outcomes

  1. 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].

    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.

    Time frame: 5 Years

  2. Assessment of Adverse Events from liposuction procedure [Safety and Tolerability].

    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.

    Time frame: 5 Years

Secondary outcomes

  1. 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.

    Measurement and photography of the fistula in endoscopic/bronchoscopic evaluation.

    Time frame: 16 weeks

  2. Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to improve the success of surgical repair in reducing cardinal symptoms.

    Documentation of reduction of cardinal symptoms by history and physical examination.

    Time frame: 5 Years

  3. Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to prevent recurrence of aerodigestive fistulae or enterocutaneous fistulae.

    Documentation of fistula recurrence by long term follow-up.

    Time frame: 5 Years

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 18, 2018
  • Informed consent form · Sep 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03792360
Lead sponsor
Mayo Clinic
Responsible party
Bhaumik Brahmbhatt (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 3, 2019
Start date
Feb 2021 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Apr 6, 2023

Study contacts

Bhaumik Brahmbhatt
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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