Adipose Derived SVF for Aero-digestive & Enterocutaneous Fistulae
Stopped: Study closed due to lack of patient enrollment.
0Started 2021-02
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Criteri…
What they're measuring
1
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].
Timeframe: 5 Years
2
Assessment of Adverse Events from liposuction procedure [Safety and Tolerability].