Conservative Treatment of Gastrointestinal Fistulas by Endoscopic Injection of tSVFem
NCT ID: NCT04670276
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-11-02
2022-04-10
Brief Summary
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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.
Detailed Description
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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. Indeed, the anti-inflammatory and regenerative-tissue promoting effects of tSVFem may safely promote rapid and effective tissue healing as alternative, and in this setting they were not investigated before. Fistulas are often long-standing chronic conditions, thus healing mechanisms are delayed and subverted in favor of inflammation and fibrosis, resembling chronic inflammatory diseases. Delivery of tSVFem is a promising new approach that promotes healing in virtue of its immunosuppressive, immunomodulatory, pro-angiogenic and regenerative potentials. Since the grafted material used in this study is autologous, there is no risk for rejection. All the procedures are performed under general anesthesia with orotracheal intubation or laryngeal mask. Approximately 30 cc of fat are harvested from the superficial layer of subcutaneous tissue by a 2.1 mm microcannula with 4, 1-mm size holes, arranged in a single raw, to get the so-called "microfat". Twenty cc of the harvested microfat are mechanical emulsified by sequential passages through 2.4mm and 1.2mm filters, and a 600/400 μm disposable filtering device.
Then the material is centrifuged at 3000 rounds for three minutes, obtaining the tSVFem after removal of supernatant fraction and oil released upon mature adipocytes mechanical disruption.
Subsequently, an endoscopy is performed to inject 10 cc of microfat into the fistula (through a 6-French catheter) until it was completely filled. Then, with a 22 Gauge endoscopic needle, a total of 1-2 cc of tSVFem were injected into the submucosa of the 4 quadrants of the fistula borders, to obliterate it completely.
A radiologic and endoscopic control at day-7 is done to evaluate complete healing of the fistula.
The technique proposed by the investigators 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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental arm
Patients treated by endoscopic injection of emulsified adipose tissue stromal vascular fraction
injection of emulsified adipose tissue stromal vascular fraction
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.
Interventions
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injection of emulsified adipose tissue stromal vascular fraction
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who do not sign informed consent form
18 Years
ALL
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Venanzio Porziella
Assistant professor
Principal Investigators
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Venanzio Porziella, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Fondazione Policlinico Agostino Gemelli IRCCS
Roma, , Italy
Countries
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Central Contacts
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Dania Nachira
Role: CONTACT
Phone: 00390630155692
Facility Contacts
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Venanzio Porziella
Role: primary
References
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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.
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.
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.
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.
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.
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
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.
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.
Other Identifiers
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3127 prot.num 0043082/20
Identifier Type: -
Identifier Source: org_study_id