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Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae

NCT03792360 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-04-06

No results posted yet for this study

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.

Conditions

  • Tracheoesopharyngeal Fistula
  • Bronchoesophageal Fistula
  • Tracheoesophageal Fistula

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Bhaumik Brahmbhatt · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2027-02-28
Completion
2028-02-29
FDA Drug
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792360 on ClinicalTrials.gov