Treatment of anal fistulas using stem cells
Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
This study is testing if a new stem cell treatment can help people with complex anal fistulas caused by Crohn's disease feel better after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT05974280 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with complex anal fistulas related to Crohn's disease who have not responded to conventional therapies.
Not a fit: Patients who are pregnant, breastfeeding, or have hypersensitivity to the treatment components will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from difficult-to-treat anal fistulas.
How similar studies have performed: Other studies have explored stem cell therapies for similar conditions, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nantes
- CHU Nantes — Nantes, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.