Treatment of Perianal Fistulas in Crohn's Disease With Autologous Microfragmented Adipose Tissue With the Lipogems® System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Demonstration of fistula healing
Study Overview
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.
Detailed Description
Crohn's disease is a chronic inflammatory disease of unknown etiology, probably multifactorial, which can affect the entire digestive tract but especially the terminal ileum. Its incidence is increasing exponentially, resulting in a growing care commitment and an increasingly onerous economic burden for the NHS.
In 25% - 80% of patients with m. Crohn's disease there is an involvement of the perianal tissues due to particularly disabling symptoms such as pain, chronic mucopurulent secretions, recurrent acute septic episodes which, in over a third of cases, result in complex anal and ano-vaginal fistulas with the need for hospitalization multiple and significant impairment of the quality of socio-relational and working life.
The treatments currently available for perianal Crohn's are mainly based on the use of biological drugs known both for their high cost and for their important side effects, but 37% of patients present recurrence or persistence of the disease with the need to resort to surgery . In about 90% of cases, the surgery is repeated more than once, resulting in a significantly increased risk of faecal incontinence.
Sometimes a stoma and proctectomy may be necessary. Göttgens KW et al. highlight how, in the last twenty years, the risk of developing a perianal fistula has remained substantially stable, as well as its recurrence rate, underlining the need to improve treatment strategies.
The COVID-19 pandemic has further complicated the clinical management of patients with m. Crohn's disease both due to the need to limit their mobility and access to healthcare settings and due to the fear that immunosuppressive and immunomodulatory therapies could expose them to a greater risk of infection and complications. Although an increase in the incidence of SARS COVID-19 infection is not currently demonstrated in this subpopulation of patients, it could, however, be more vulnerable to COVID-19. In fact, it has been seen how the SARS-CoV 2 virus enters the cells by binding to the ACE2 receptors which are overexpressed at the level of the inflamed intestinal epithelium and constitute a potential entry route for the virus into the human body. Furthermore, a recent international survey has shown that it is common practice to suspend biological therapy in patients with m. Crohn's disease infected with SARS-CoV 2.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Previously treated patients (recurring fistulas) will also be included. Even the presence of a stoma or lax seton will not constitute grounds for exclusion.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Demonstration of fistula healing
Time Frame: Two months after surgery
Demonstration of fistula healing by proctological objective examination.
Secondary Outcomes
- Positive change in quality of life(Evaluation at screening and follow-up, two months after surgery)
Investigators
Dr. Fabio Marino - MD
Principal Investigator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis