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Treatment of Perianal Fistulas in Crohn's Disease With Autologous Microfragmented Adipose Tissue With the Lipogems System

NCT05766566 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-03-16

No results posted yet for this study

Summary

The aim of the study is to verify the efficacy of microfragmented autologous adipose tissue with the Lipogems® system, in the treatment of perianal fistulas of m. Crohn's.

The Lipogems® International, Milan, Italy, system is a sterile and disposable device that allows to harvest adipose tissue, process it and use it for intraoperative autologous transplantation of human adipose tissue mesenchymal cells that have a gene expression profile and phenotypic similar to that of adipose stem cells.

The system consists of a container with metal beads capable of carrying out, by handling, a mechanical micro-fragmentation of the lipoaspirate and of a washing and filtering system which allows to progressively reduce the size of the adipose tissue clusters down to 0.2-0.8 mm and eliminate blood and oily residues.

The processed Lipogems® is fluid and easily injectable and is rich in mesenchymal cells and pericytes.

The processed Lipogems® will be injected around the fistulous tract and the tissue area closing the internal orifice to promote healing.

Conditions

  • Crohn Disease
  • Fistula
  • Adipose Tissue

Interventions

PROCEDURE

Perianal fistula surgery

surgical treatment of the perianal fistula through curettage, closure with suture thread (vicryl 2/0) of the internal orifice and lipofilling of the passage with microfragmented autologous adipose tissue processed with the Lipogems® system.

Sponsors & Collaborators

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    lead OTHER

Principal Investigators

  • Fabio Marino, MD · IRCCS "Saverio de Bellis" - Castellana Grotte (BA) - Italy

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2024-04-01
Completion
2025-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766566 on ClinicalTrials.gov