Clinical trial NCT03792360: Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Tracheoesopharyngeal Fistula
Bronchoesophageal Fistula
Tracheoesophageal Fistula
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: 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].
timeFrame: 5 Years
measure: Assessment of Adverse Events from liposuction procedure [Safety and Tolerability].
timeFrame: 5 Years
Secondary outcomes:
measure: 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.
timeFrame: 16 weeks
measure: Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to improve the success of surgical repair in reducing cardinal symptoms.
timeFrame: 5 Years
measure: Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to prevent recurrence of aerodigestive fistulae or enterocutaneous fistulae.
timeFrame: 5 Years
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Bhaumik Brahmbhatt
role: PRINCIPAL_INVESTIGATOR
References: