Recruiting

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

NCT05974280 · Nantes University Hospital

Recruiting

In plain English

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Official title

Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells

About this study

The trial will be made available to patients who are scheduled for perianal surgery with ALOFISEL® or backup (fat injection). The history and signs of perianal fistula will be noted if the patient doesn't object. Two visits that correspond to typical follow-up visits for patients will be noted: Visit following surgery: fistula clinical evaluation, analgesic use, etc. and six months after : clinical assessment, MRI

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.

Study design

Enrollment target: 20 participants

Age groups: adult, older_adult

Timeline

Starts: 2024-01-02

Estimated completion: 2027-06-02

Last updated: 2026-06-24

Interventions

Drug: AlofiselDrug: Fat stem cell

Primary outcomes

• Comparing the efficacy of Alofisel treatment versus fat grafting in Crohn's disease complex perianal fistulae (1 month after the surgery)

Sponsor

Nantes University Hospital · other

All locations (1)

CHU NantesRecruiting

Nantes, Nantes, France

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