Adipose Derived SVF for Aero-digestive Fistulae

Brief Title

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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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].

Secondary Outcome

 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.

Condition

Tracheoesopharyngeal Fistula

Intervention

SVF (Stromal Vascular Fraction)

Study Arms / Comparison Groups

 Single Arm
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

February 28, 2021

Completion Date

February 28, 2028

Primary Completion Date

February 28, 2027

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
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Bhaumik Brahmbhatt, (904) 953 7971, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03792360

Organization ID

17-003774


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

Bhaumik Brahmbhatt, Principal Investigator, Mayo Clinic


Verification Date

March 2021