Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.

Launched by LIPOGEMS INTERNATIONAL SPA · Oct 21, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people with Crohn's disease who have complex perianal fistulas that haven't improved with standard treatments. A perianal fistula is an abnormal connection between the anal area and the skin, which can be painful and difficult to manage. In this study, researchers are testing the effectiveness of injecting a special type of fat taken from the patient's own body (called micro-fragmented autologous adipose tissue) to help heal these painful fistulas. The goal is to improve patients' quality of life and reduce the need for more drastic surgeries, like creating an ostomy.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with Crohn's disease. They should also have perianal fistulas that have not responded to at least a year of standard treatment, which includes surgery and medications. Participants will need to understand the study's purpose and agree to be part of it. While the trial is currently active, it's important to note that it is not recruiting new participants at this time, and there are specific medical conditions that could prevent someone from joining, such as certain infections or other serious health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient's age is over 18 at the time of surgery.
• • The patient suffers from Crohn's disease confirmed by instrumental and histological methods.
• • The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year)
• • The patient received, understood and signed informed consent for active participation in the study.
• • The patient is able to understand the conditions of the study and to participate throughout the duration.
• Exclusion Criteria:
• • Patients with more than 1 internal and 3 external openings.
• • Patients with ileus / colo ostomy.
• • Patients with anus / rectum-vaginal fistulas.
• • Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis.
• • Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
• • Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc).
• • Patients with clinical conditions that may compromise the success of the surgery or the follow-up.
• • Pregnant or breastfeeding women.