Tracheoesopharyngeal FistulaPhase 1NCT03792360
Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae
A Phase 1 study testing SVF (Stromal Vascular Fraction) in people with Tracheoesopharyngeal Fistula and Bronchoesophageal Fistula, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tracheoesopharyngeal Fistula, Bronchoesophageal Fistula, Tracheoesophageal Fistula
- What is being tested?
- SVF (Stromal Vascular Fraction)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Feb 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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 this study
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
Determine safety and feasibility of using institutionally prepared autologous, uncultured SVF on patients with aerodigestive and enterocutaneous fistulae secondary to malignancy, trauma or surgery.
Read the 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.
- Being tested
- SVF (Stromal Vascular Fraction)
- Medical subject headings
- Tracheoesophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVF (Stromal Vascular Fraction)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: SVF (Stromal Vascular Fraction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 Years
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.
Measured: 5 Years
Secondary outcomes (3)
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.
Measured: 16 weeks
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.
Measured: 5 Years
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.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study startFeb 2021 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: Study closed due to lack of patient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheoesopharyngeal FistulaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhaumik Brahmbhatt, Mayo Clinic
- Investigators
- Bhaumik Brahmbhatt, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792360
- Sponsor's protocol ID
- 17-003774
- Status last verified
- Apr 2023
- First submitted
- 21 Nov 2018
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03792360
- Acronym / sponsor ID
- 17-003774
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed due to lack of patient enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: SVF (Stromal Vascular Fraction) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SVF (Stromal Vascular Fraction)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. | Drug | Single Arm |
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].
Time frame: 5 Years
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].
Time frame: 5 Years
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.
3 secondary outcomes
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.
Time frame: 16 weeks
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to improve the success of surgical repair in reducing cardinal symptoms.
Time frame: 5 Years
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to prevent recurrence of aerodigestive fistulae or enterocutaneous fistulae.
Time frame: 5 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhaumik Brahmbhatt principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SVF (Stromal Vascular Fraction) in people with Tracheoesopharyngeal Fistula and Bronchoesophageal Fistula, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]. (time frame: 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.