Actively Recruiting
Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
Led by Nantes University Hospital · Updated on 2024-12-27
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for difficult perianal fistulas in adults with Crohn's Disease. This study compares two types of stem cell injections: Alofisel, a medicine made from donor fat tissue stem cells, and autologous fat stem cell injections from the patient's own fat. The goal is to evaluate which approach is more effective for complex anal fistulas that have not improved with usual treatments. Participants scheduled for surgery will either receive Alofisel or autologous fat stem cell injections as part of routine care. Only one patient receives Alofisel per dose, while another patient serves as a backup and receives the fat stem cell injection. Both treatments involve injections during surgery, with follow-up visits planned to monitor progress. During the study, patients will have two main follow-up visits: one after surgery for clinical evaluation and pain management, and another six months later including a clinical assessment and MRI scan. Researchers will compare the effectiveness of the two treatments one month after surgery by assessing fistula healing and other clinical outcomes. The study is sponsored by Nantes University Hospital and participation lasts at least six months.
CONDITIONS
Brief Title
Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Complex anal fistula with inactive or slightly active Crohn's disease under conventional treatment or biotherapy
- MRI confirmation of effective drainage
- Maximum of two internal orifices and three external orifices
- Persistence of fistulas despite closing of internal orifices
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients allergic or hypersensitive to Alofisel, bovine serum, or any excipients
- Vulnerable persons such as those deprived of liberty, under guardianship, or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants scheduled for perianal surgery receive either Alofisel or autologous fat stem cell injections as part of routine care.
1 visit (in-person) on the day of surgery
Duration - 6 months after surgery
Participants are followed up to evaluate fistula healing, analgesic use, and clinical assessment including MRI.
2 visits (in-person): one visit shortly after surgery and one visit 6 months later
Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, France, 44000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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