Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae

Mayo Clinic

Status and phase

Withdrawn

Phase 1

Conditions

Bronchoesophageal Fistula

Tracheoesopharyngeal Fistula

Tracheoesophageal Fistula

Treatments

Drug: SVF (Stromal Vascular Fraction)

Study type

Interventional

Funder types

Other

Identifiers

NCT03792360

17-003774

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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