Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
Doctors are looking into new ways to treat anal fistulas in people with Crohn's disease. This study compares two types of treatment: Alofisel, a recently approved cell therapy made from donated cells, and a treatment that uses cells from a person's own body fat. Anal fistulas are often difficult to treat, especially in people with Crohn's, and don't always get better with usual medicines. This research aims to understand if one of these cell-based injections works better than the other. The study will look at patients already scheduled to receive Alofisel or fat injection, checking how their fistulas heal and whether they need less pain relief after treatment.
At a glance
What is this study about?
If you have Crohn's disease, you might know that anal fistulas can be a really challenging problem. They are tunnels that form between the end of your bowel and the skin around your bottom, and they can be painful and hard to heal, even with standard treatments. Researchers are always looking for better solutions.
This study is comparing two new treatment approaches for these complex anal fistulas. One is a special cell therapy called Alofisel. This treatment uses healthy cells from a donor to help your fistula heal. The other approach involves using your own body fat. Doctors can take a small amount of fat, process it to get special ‘stem cells’ from within the fat, and then inject these cells back into the area around the fistula to help it repair itself.
The main goal of this research is to see which of these two cell-based injection treatments works best for people with Crohn's-related anal fistulas. By comparing them, doctors hope to find a more effective way to help these difficult fistulas close and improve your quality of life.
Key takeaways
- Compares two cell-based treatments for anal fistulas in Crohn's disease.
- Alofisel uses donor cells; 'fat stem cells' use your own cells.
- Aims to find which treatment works best for healing complex fistulas.
- Participation involves monitoring your fistula during routine follow-up appointments.
- Only for adults with complex anal fistulas related to stable Crohn's disease.
- Your care will not be affected if you choose not to participate.
Who may be eligible?
This study is particularly for adults (aged 18 and over) who have a complex anal fistula related to their Crohn's disease, and who haven't responded well to other treatments. The fistula needs to have been properly drained, and MRI scans will be used to confirm its details.
To be considered, your Crohn's disease in your gut should be stable or only mildly active, meaning it's under control with your current medications. The fistula can have up to two internal openings and three external openings, and it should still be there even after any internal openings have been closed.
You won't be able to join the study if you are pregnant or breastfeeding, or if you have ever had a serious allergic reaction to Alofisel, products containing bovine (cow) serum, or any of its ingredients. Also, people who are unable to make their own decisions about taking part, for example, if they are under legal guardianship, cannot join this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a complex anal fistula related to Crohn's disease?
- Has your Crohn's disease in your gut been stable or mildly active?
- Have you not responded well to at least one other treatment for your fistula?
- Are you currently not pregnant or breastfeeding?
- Do you not have any severe allergies to Alofisel or related ingredients?
What does participation involve?
If you decide to take part, you'll be one of the patients already planning to have either the Alofisel treatment or the fat injection for your anal fistula. The researchers will simply ask your permission to gather some information about your fistula.
After your operation, there will be two follow-up visits. These visits are usually part of your normal care anyway. The first visit will be shortly after your surgery, where the doctors will check how your fistula is healing and how much pain relief you're using. The second visit will be about six months after your surgery. At this visit, the doctors will again check your fistula, and you'll likely have an MRI scan to get a detailed picture of the healing process.
Potential risks and benefits
Locations (1)
- CHU NantesVerified postcodeNantes, France· Recruiting
Common questions
What is an anal fistula?
An anal fistula is a small tunnel that can form under the skin between the end of your bowel and the skin around your bottom. It's often linked to Crohn's disease.
What is Alofisel?
Alofisel is a special cell therapy that uses healthy cells from a donor to help heal difficult anal fistulas, especially when other treatments haven't worked well.
What are 'fat stem cells'?
These are special cells taken from your own body fat. They have properties that can help repair tissues and reduce inflammation, and they are injected around the fistula.
Will I know which treatment I'm getting?
Yes, you will be receiving either the Alofisel treatment or the fat injection as part of your planned care. The study is comparing these two treatments.
How long will the study follow me?
The study will gather information from two follow-up visits after your surgery. One shortly after and another about six months later, which would normally be part of your care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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