SVF (Stromal Vascular Fraction) for Tracheoesophageal Fistula

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Florida, Jacksonville, FLTracheoesophageal Fistula+2 MoreSVF (Stromal Vascular Fraction) - Drug
Eligibility
18 - 90
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether it is safe and feasible to use a person's own fat cells to treat fistulas resulting from cancer, trauma, or surgery.

Eligible Conditions
  • Tracheoesophageal Fistula
  • Bronchoesophageal Fistula

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Autologous Adipose-Derived SVF (Stromal Vascular Fraction)

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 5 Years

16 weeks
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.
5 Years
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].
Assessment of Adverse Events from liposuction procedure [Safety and Tolerability].
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to improve the success of surgical repair in reducing cardinal symptoms.
Assessment of efficacy of Stromal Vascular Fraction's (SVF)'s ability to prevent recurrence of aerodigestive fistulae or enterocutaneous fistulae.

Trial Safety

Safety Progress

1 of 3

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1
MSC-AFP
1
Mesenchymal stem cells
1
Autologous Adipose-Derived SVF (Stromal Vascular Fraction)

Trial Design

1 Treatment Group

Single Arm
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: SVF (Stromal Vascular Fraction) · No Placebo Group · Phase 1

Single Arm
Drug
Experimental Group · 1 Intervention: SVF (Stromal Vascular Fraction) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,960 Previous Clinical Trials
3,449,476 Total Patients Enrolled
Bhaumik BrahmbhattPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital Jacksonville

Eligibility Criteria

Age 18 - 90 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have recurring or new abnormal connections or openings between organs or tissues.
You have been diagnosed with advanced or metastatic cancer and standard treatment has not been effective or is not an option for you.
You have abnormal connections or openings between your respiratory or digestive tracts and your skin, or between different parts of your digestive tract.
You have a fistula, which is an abnormal connection between two organs in your body. The causes of the fistula may include past cancer, previous radiation treatment (if you have been in complete remission for five years), birth defects, previous surgeries or procedures, prolonged use of a breathing tube, certain conditions like inflammatory bowel disease, foreign object ingestion, chest injuries, caustic ingestion, pneumonectomy or mechanical ventilation, or a condition called esophagomalacia.
References

Frequently Asked Questions

What adverse effects should individuals be cognizant of when undergoing SVF treatment?

"In the opinion of our team at Power, SVF (Stromal Vascular Fraction) is a relatively safe intervention with score of 1. This rating was based on its Phase 1 clinical trial status; meaning that only preliminary information exists in regards to effectiveness and safety." - Anonymous Online Contributor

Unverified Answer

Does this research include adults aged 18 and older as participants?

"In accordance with the trial's parameters, a minimum age of 18 and upper limit of 90 is necessary for enrollment." - Anonymous Online Contributor

Unverified Answer

How many individuals are contributing to the research by taking part in this trial?

"Affirmative. The findings on clinicaltrials.gov verify that this study, initially posted on February 28th 2021, is actively recruiting participants. Ten test subjects are required from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Are there still available slots for participants in this experiment?

"Affirmative. The data on clinicaltrials.gov confirms that this research endeavour, which was first advertised on February 28th 2021 is actively recruiting participants. Specifically the project requires 10 individuals from a single study site." - Anonymous Online Contributor

Unverified Answer

Might I be able to join this experiment?

"This clinical trial has a capacity of 10 persons suffering from tracheoesophageal fistula, the ages for which range between 18 and 90. A list of requirements should be met in order to qualify: biopsy forceps-measured opening size must measure 2 mm - 15 mm, patient is an adult within the specified age bracket, recurrent or de novo fistulas/sinus tracts are present and have failed prior treatment attempts, and types including tracheopharyngeal, bronchoesophageal as well as gastric/duodenal/jejunal/ileal etc., with communication to skin (" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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