Conservative Treatment of Gastrointestinal Fistulas by Endoscopic Injection of tSVFem (tSVFem)

December 10, 2020 updated by: Venanzio Porziella, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conservative Treatment of Gastrointestinal Fistulas by Endoscopic Injection of Emulsified Adipose Tissue Stromal Vascular Fraction (tSVFem)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal fistula may be a life-threatening condition caused by several types of injuries (iatrogenic, traumatic, post-operative), requiring complex and multidisciplinary management. To date, no clear guidelines have been drawn up for the treatment, that may include a conservative, minimally invasive, or major surgical approach depending on the patient's specific clinical characteristics. Furthermore, patients with fistulas are often fragile, and surgical treatments are highly risky and invasive. Less invasive treatments such as stenting, endoluminal endoscopic vacuum therapy and suturing are widely employed, but these treatments often require long hospitalization, highly skilled operators, without certain results and with high rates of complications.

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dania Nachira
  • Phone Number: 00390630155692

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Agostino Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Venanzio Porziella, MD
        • Sub-Investigator:
          • Dania Nachira, MD
        • Principal Investigator:
          • Angelo Trivisonno, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental arm
Patients treated by endoscopic injection of emulsified adipose tissue stromal vascular fraction
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula healing
Time Frame: 7 days after the injection procedure of tSVFem
Rate of healing of fistula at endoscopy and gastrografin swallow
7 days after the injection procedure of tSVFem

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment adverse events and complications
Time Frame: During the procedure, 7 days after and at 1-2 month follow-up
To evaluate the percentage of patients that developed adverse events or any complications during and after the treatment proposed
During the procedure, 7 days after and at 1-2 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Venanzio Porziella, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2020

Primary Completion (ANTICIPATED)

March 2, 2022

Study Completion (ANTICIPATED)

April 10, 2022

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (ACTUAL)

December 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3127 prot.num 0043082/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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