Conservative Treatment of Gastrointestinal Fistulas by Endoscopic Injection of tSVFem

NCT04670276 | Unknown

• 1 other identifier: 3127 prot.num 0043082/20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Fistula

Keywords

gastrointestinal fistula; Adipose-derived stem cells; adipose tissue stromal vascular fraction; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Fistula healing

  Rate of healing of fistula at endoscopy and gastrografin swallow

  7 days after the injection procedure of tSVFem

Secondary Outcomes (1)

• Incidence of treatment adverse events and complications

  During the procedure, 7 days after and at 1-2 month follow-up

Study Arms (1)

Experimental arm

EXPERIMENTAL

Patients treated by endoscopic injection of emulsified adipose tissue stromal vascular fraction

Procedure: injection of emulsified adipose tissue stromal vascular fraction

Interventions

injection of emulsified adipose tissue stromal vascular fraction PROCEDURE

Endoscopic injection of 10 cc of autologous microfat into the fistula (through a 6-French catheter), until it was completely filled, and a total of 1-2 cc of tSVFem (through a 22G endoscopic needle) into the submucosa of the 4 quadrants of the fistula borders, to obliterate it completely.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by GI fistulas, not fit for surgical treatments of after failure of conventional conservative treatments

You may not qualify if:

• Enteroenteric fistulas
• Patients who do not sign informed consent form

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (8)

• Brinster CJ, Singhal S, Lee L, Marshall MB, Kaiser LR, Kucharczuk JC. Evolving options in the management of esophageal perforation. Ann Thorac Surg. 2004 Apr;77(4):1475-83. doi: 10.1016/j.athoracsur.2003.08.037.

  PMID: 15063302 BACKGROUND

• Porziella V, Nachira D, Boskoski I, Trivisonno A, Costamagna G, Margaritora S. Emulsified stromal vascular fraction tissue grafting: a new frontier in the treatment of esophageal fistulas. Gastrointest Endosc. 2020 Dec;92(6):1262-1263. doi: 10.1016/j.gie.2020.06.019. Epub 2020 Jul 4. No abstract available.

  PMID: 32634381 BACKGROUND

• Kuehn F, Loske G, Schiffmann L, Gock M, Klar E. Endoscopic vacuum therapy for various defects of the upper gastrointestinal tract. Surg Endosc. 2017 Sep;31(9):3449-3458. doi: 10.1007/s00464-016-5404-x. Epub 2017 Jan 11.

  PMID: 28078463 BACKGROUND

• Brangewitz M, Voigtlander T, Helfritz FA, Lankisch TO, Winkler M, Klempnauer J, Manns MP, Schneider AS, Wedemeyer J. Endoscopic closure of esophageal intrathoracic leaks: stent versus endoscopic vacuum-assisted closure, a retrospective analysis. Endoscopy. 2013 Jun;45(6):433-8. doi: 10.1055/s-0032-1326435. Epub 2013 Jun 3.

  PMID: 23733727 BACKGROUND

• Ceccarelli S, Pontecorvi P, Anastasiadou E, Napoli C, Marchese C. Immunomodulatory Effect of Adipose-Derived Stem Cells: The Cutting Edge of Clinical Application. Front Cell Dev Biol. 2020 Apr 17;8:236. doi: 10.3389/fcell.2020.00236. eCollection 2020.

  PMID: 32363193 BACKGROUND

• Angelo Trivisonno, Marc Abecassis, Massimo Monti et al. Adipose Tissue: From Energy Reservoir to a Source of Cells for Epithelial Tissue Engineering. In: Stem Cells in Aesthetic Procedures: Springer Berlin Heidelberg,2014:303-326

  BACKGROUND

• Trivisonno A, Nachira D, Boskoski I, Calcagni F, Tringali A, Costamagna G, Margaritora S, Porziella V. Autologous Fat Grafting Restores Soft-tissue Contour Deformities after Vascular Anomaly: Widening the Horizons of Employment of Autologous Fat Grafting. Plast Reconstr Surg Glob Open. 2019 Nov 27;7(11):e2518. doi: 10.1097/GOX.0000000000002518. eCollection 2019 Nov. No abstract available.

  PMID: 31942308 BACKGROUND

• Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016 Sep 24;388(10051):1281-90. doi: 10.1016/S0140-6736(16)31203-X. Epub 2016 Jul 29.

  PMID: 27477896 BACKGROUND

MeSH Terms

Conditions

Digestive System Fistula

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Venanzio Porziella, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dania Nachira, MD

CONTACT

00390630155692; dania.nachira@policlinicogemelli.it

Dania Nachira

CONTACT

00390630155692

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 17, 2020
• Study Start: November 2, 2020
• Primary Completion: March 2, 2022
• Study Completion: April 10, 2022
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)