Back to resultsAdipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae
Primary Purpose
Tracheoesopharyngeal Fistula, Bronchoesophageal Fistula, Tracheoesophageal Fistula
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SVF (Stromal Vascular Fraction)
Sponsored by
About this trial
This is an interventional treatment trial for Tracheoesopharyngeal Fistula
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
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].
Documentation of signs of adverse reactions from intravascular application of TISEEL, including: intravascular coagulation, thromboembolic events and acute hypersensitivity reactions. Documentation of signs of increased fistula size and/or aggravation of symptoms associated with fistulous tract, including: paroxysmal cough, dysphagia, wheezing, abdominal distention, chest pain, dyspnea, pneumonia.
Assessment of Adverse Events from liposuction procedure [Safety and Tolerability].
Signs of adverse reactions to the lipoaspiration procedure, including: allergic reaction to Hunstad solution, infection at the puncture wound site or risk of bleeding at the puncture wound site.
Secondary Outcome Measures
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.
Measurement and photography of the fistula in endoscopic/bronchoscopic evaluation.
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to improve the success of surgical repair in reducing cardinal symptoms.
Documentation of reduction of cardinal symptoms by history and physical examination.
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to prevent recurrence of aerodigestive fistulae or enterocutaneous fistulae.
Documentation of fistula recurrence by long term follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03792360
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study closed due to lack of patient enrollment.
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheoesopharyngeal Fistula, Bronchoesophageal Fistula, Tracheoesophageal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SVF (Stromal Vascular Fraction)
Intervention Description
The stromal vascular fraction (SVF), isolated when fresh lipoaspirates are enzymatically digested with a collagenase, contains a heterogeneous cellular and extracellular milieu. SVF is an aqueous fraction, consisting of endothelial cells and their precursors, macrophages, smooth muscle cells, lymphocytes, pericytes, pre-adipocytes and actual AMSCs.
Primary Outcome Measure Information:
Title
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].
Description
Documentation of signs of adverse reactions from intravascular application of TISEEL, including: intravascular coagulation, thromboembolic events and acute hypersensitivity reactions. Documentation of signs of increased fistula size and/or aggravation of symptoms associated with fistulous tract, including: paroxysmal cough, dysphagia, wheezing, abdominal distention, chest pain, dyspnea, pneumonia.
Time Frame
5 Years
Title
Assessment of Adverse Events from liposuction procedure [Safety and Tolerability].
Description
Signs of adverse reactions to the lipoaspiration procedure, including: allergic reaction to Hunstad solution, infection at the puncture wound site or risk of bleeding at the puncture wound site.
Time Frame
5 Years
Secondary Outcome Measure Information:
Title
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.
Description
Measurement and photography of the fistula in endoscopic/bronchoscopic evaluation.
Time Frame
16 weeks
Title
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to improve the success of surgical repair in reducing cardinal symptoms.
Description
Documentation of reduction of cardinal symptoms by history and physical examination.
Time Frame
5 Years
Title
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to prevent recurrence of aerodigestive fistulae or enterocutaneous fistulae.
Description
Documentation of fistula recurrence by long term follow-up.
Time Frame
5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhaumik Brahmbhatt
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae
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