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
Overview
- Phase
- Phase 1
- Intervention
- SVF (Stromal Vascular Fraction)
- Conditions
- Tracheoesopharyngeal Fistula
- Sponsor
- Mayo Clinic
- Primary Endpoint
- 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].
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Bhaumik Brahmbhatt
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Single Arm
Intervention: SVF (Stromal Vascular Fraction)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to prevent recurrence of aerodigestive fistulae or enterocutaneous fistulae.(5 Years)
- 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)