← Back to Search

Cell Therapy

SVF (Stromal Vascular Fraction) for Tracheoesophageal Fistula

Phase 1

Waitlist Available

Led By Bhaumik Brahmbhatt

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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].

Assessment of Adverse Events from liposuction procedure [Safety and Tolerability].

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.

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 Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,227 Previous Clinical Trials

3,771,668 Total Patients Enrolled

Bhaumik BrahmbhattPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital Jacksonville

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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 ("

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae

Bhaumik Brahmbhatt 2021. "Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03792360.