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

NCT05766566 | Unknown

• 1 other identifier: Lipogems
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lipogems

Outcome Measures

Primary Outcomes (1)

• Demonstration of fistula healing

  Demonstration of fistula healing by proctological objective examination.

  Two months after surgery

Secondary Outcomes (1)

• Positive change in quality of life

  Evaluation at screening and follow-up, two months after surgery

Study Arms (1)

Cohort

Will be enrolled patients referring to the Department of General Surgery of the IRCCS "Saverio de Bellis" - Castellana Grotte (BA) Italy, affected by perianal fistulas from Crohn's disease.

Procedure: Perianal fistula surgery

Interventions

Perianal fistula surgery PROCEDURE

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.

Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referring to the Department of General Surgery of the IRCCS "Saverio de Bellis" - Castellana Grotte (BA) Italy, affected by perianal fistulas from Crohn's disease will be enrolled.

You may qualify if:

• Patients aged over 18 and under 80 of both sexes
• Patients with single or multiple perianal fistulae of M. Crohn's not amenable to fistulotomy(due to involvement of the sphincters)
• Patients without acute local sepsis
• Patients who have had Crohn's disease in stable remission for at least 6 months.

You may not qualify if:

• Patients with cryptogenic perianal fistulas
• Patients with large incisional hernias that could favor intestinal perforations during the abdominal liposuction phase
• Patients with history of previous neoplastic pathologie

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

Unit of General Surgery, National Institute of Gastroenterology - IRCCS "Saverio de Bellis"

Castellana Grotte, Bari, 70013, Italy

RECRUITING

Related Publications (5)

• Ruffolo C, Citton M, Scarpa M, Angriman I, Massani M, Caratozzolo E, Bassi N. Perianal Crohn's disease: is there something new? World J Gastroenterol. 2011 Apr 21;17(15):1939-46. doi: 10.3748/wjg.v17.i15.1939.

  PMID: 21528071 BACKGROUND

• Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.

  PMID: 11910338 BACKGROUND

• Rius J, Nessim A, Nogueras JJ, Wexner SD. Gracilis transposition in complicated perianal fistula and unhealed perineal wounds in Crohn's disease. Eur J Surg. 2000 Mar;166(3):218-22. doi: 10.1080/110241500750009311.

  PMID: 10755336 BACKGROUND

• Mizuno H, Zuk PA, Zhu M, Lorenz HP, Benhaim P, Hedrick MH. Myogenic differentiation by human processed lipoaspirate cells. Plast Reconstr Surg. 2002 Jan;109(1):199-209; discussion 210-1. doi: 10.1097/00006534-200201000-00030.

  PMID: 11786812 BACKGROUND

• Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

  PMID: 11304456 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Fistula

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabio Marino, MD

  IRCCS "Saverio de Bellis" - Castellana Grotte (BA) - Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Marino, MD

CONTACT

3409351886; fabio.marino@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 13, 2023
• Study Start: March 7, 2023
• Primary Completion: April 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)