Study Evaluating the Safety and Feasibility of Using Human Cell Therapy for the Treatment of Aerodigestive Fistulae in Adults

Overview

About this study

The purpose of this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Adults ≥ 18 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;
    • Tracheoesophogal;
    • Bronchoesophogal.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Timothy Woodward, M.D.

Contact us for the latest status

Contact information:

Natalie Fares

(904)953-3880

Fares.Natalie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20441562

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