Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells

Launched by NANTES UNIVERSITY HOSPITAL · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring two different treatments for complex anal fistulas related to Crohn's disease. The first treatment being studied is called ALOFISEL®, a new cell therapy that uses stem cells derived from fat tissue. This treatment is intended for patients who have not had success with other therapies. The second option is an injection of the patient’s own fat, which is also rich in stem cells. The goal is to find out which treatment is more effective in healing these challenging fistulas.

To be eligible for the trial, participants must have a complex anal fistula that continues to cause issues despite other treatments. They should be adults aged 18 and older, and certain individuals, such as pregnant women or those with specific allergies, will not be able to participate. If someone joins the trial, they can expect to receive one of the two treatments and will be monitored to see how well it helps their condition. It's important to note that ALOFISEL® is quite expensive, and only one of two patients scheduled for treatment will actually receive it to ensure that the backup patient is ready if needed.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Complex anal fistula with the following criteria: - Inactive/slightly active luminal Crohn's disease under conventional treatment or biotherapy MRI has demonstrated effective drainage. Maximum of two internal orifices and three external orifices; persists despite internal orifice(s) closing.
• Exclusion Criteria:
• • Pregnant or breast-feeding women
• • Patients hypersensitive to the product, bovine serum or any of the excipients of Alofisel
• • Vulnerable persons: deprived of liberty, under guardianship, under curatorship, etc.