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Search / Trial NCT03792360

Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae

Launched by MAYO CLINIC · Dec 31, 2018

Trial Information

Current as of July 23, 2025

Withdrawn

Keywords

ClinConnect Summary

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 th...

Gender

ALL

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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Jacksonville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Bhaumik Brahmbhatt

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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