Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae

NCT03792360 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 17-003774
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tracheoesopharyngeal Fistula; Bronchoesophageal Fistula; Tracheoesophageal Fistula

Outcome Measures

Primary Outcomes (2)

• 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.

  5 Years

• 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.

  5 Years

Secondary Outcomes (3)

• 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.

  16 weeks

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

  5 Years

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

  5 Years

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: SVF (Stromal Vascular Fraction)

Interventions

SVF (Stromal Vascular Fraction) DRUG

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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Tracheoesophageal Fistula

Condition Hierarchy (Ancestors)

Esophageal Fistula; Digestive System Fistula; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Fistula; Respiratory Tract Diseases; Tracheal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Bhaumik Brahmbhatt

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: January 3, 2019
• Study Start: February 1, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share