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NCT04670276: tSVFem

Conservative Treatment of Gastrointestinal Fistulas by Endoscopic Injection of tSVFem

Status unknown NA Last updated 17 December 2020
What this trial tests

NA trial testing injection of emulsified adipose tissue stromal vascular fraction in Gastrointestinal Fistula in 30 participants. Status unknown.

Timeline
2 November 2020
Primary endpoint
2 March 2022
10 April 2022

Quick facts

Lead sponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date2 November 2020
Primary completion2 March 2022
Estimated completion10 April 2022
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, any sex, with Gastrointestinal Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gastrointestinal (GI) fistula is a complex condition with high mortality and requiring a multidisciplinary management. The aim of this study is to exploit the regenerative-tissue capacities of autologous emulsified adipose tissue-derived stromal vascular fraction (tSVFem, widely used in other medical fields - like plastic surgery -for different purposes) harvested and delivered locally by endoscopy to close the GI fistula. The proposed technique for the treatment of GI fistulas with tSVFem requires a minimal, inexpensive, easily reproducible mechanical manipulation of autologous adipose tissue without necessity of any enzymatic digestion or cell expansion.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Regenerative endoscopy for the treatment of difficult gastrointestinal defects: results from a pilot trial.
    Nachira D, Pontecorvi V, Trivisonno A, Papi M, et al · · 2026 · cited 2× · PMID 40719105 · DOI 10.1055/a-2665-1777

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