Adipose Derived SVF for Aero-digestive Fistulae

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 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 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.

Inclusion Criteria:

- Adults ≥ 18 years old

- Adults ≤ 90 years old

- Aerodigestive fistula 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

- A prior diagnosis of ADF in which the standard therapy has failed or is not applicable

- Fistula location may include:

- Tracheopharyngeal

- Tracheoesophageal

- Bronchoesophageal

- 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 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, this will be excluded.Patients that require surgical
intervention at the fistula 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

- Drug or alcohol dependence

- Active infectious disease positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or
syphilis

- End of life