Treatment of anal fistulas using stem cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of ALOFISEL®, a cell therapy using allogeneic human adult mesenchymal stem cells, in treating complex anal fistulas associated with Crohn's disease. Patients scheduled for perianal surgery will be enrolled, with one receiving the treatment and the other serving as a backup. The study will involve clinical evaluations immediately after surgery and six months later, including MRI assessments to monitor treatment outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Nantes
  Nantes, Nantes, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.