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RecruitingPHASE1, PHASE2INTERVENTIONAL

Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease

This research, called ADICROHN-3, is testing a new way to treat difficult-to-heal fistulas (abnormal connections or tunnels) that can develop around the bottom (ano-perineal) in people with Crohn's disease. These are fistulas that haven't gotten better with standard treatments. The treatment involves taking a patient's own fat cells, preparing them in a special way, freezing them, thawing them, and then injecting them into the affected area. The aim is to see if these cells can help the fistulas heal. This study is a follow-up to earlier research that suggested this approach is safe and could be helpful. It's for adults aged 18 and over who have been part of a previous related study.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Assistance Publique Hopitaux De Marseille
Enrolment target
25
Start
30 Dec 2025
Estimated completion
29 Jun 2028
Crohn Disease (CD)

What is this study about?

This study, called ADICROHN-3, is focused on finding better ways to treat a specific problem that some people with Crohn's disease face: fistulas around the bottom (these are called ano-perineal fistulas). These fistulas can be very uncomfortable and difficult to manage, especially if they don't respond to usual treatments.

The researchers are studying a treatment that uses your body's own cells. They take some fat from your body, and from it, they collect special cells called "stromal vascular fraction" (SVF). These cells are then carefully prepared, frozen (cryopreserved), and stored. When it's time for treatment, these cells are thawed and injected into the area around the fistula. The idea is that these cells might help the affected tissues to heal.

This study is building on previous research. Earlier studies (like ADICROHN and ADICROHN-2) have suggested that this cell treatment is safe and shows promise in helping these difficult fistulas to get better. This new study is designed to gather more information and confirm these findings, making sure the treatment process is straightforward and exploring if a second injection could help if the first didn't fully work.

Key takeaways

  • Tests a new cell-based injection for severe Crohn's fistulas.
  • Uses your own specially prepared fat cells.
  • For adults with fistulas unresponsive to standard care.
  • Builds on promising results from previous studies.
  • Aim is to help heal difficult ano-perineal fistulas.
  • Requires previous participation in the ADICROHN-2 study.

Who may be eligible?

To be considered for this study, you must be 18 years or older and have a confirmed diagnosis of Crohn's disease for at least six months. A key requirement is that you must have previously taken part in or received treatment during the ADICROHN-2 study.

This study is specifically for people whose ano-perineal fistulas either didn't respond to the treatment in the ADICROHN-2 study or improved but then came back. Your Crohn's disease should generally be mild or inactive, and you'll need to have enough of your specially prepared cells already stored from the previous study. You must also agree to use reliable contraception if you're able to have children.

You would not be able to join if your Crohn's disease is currently very active, or if you had a bad reaction to the cell treatment in the ADICROHN-2 study. Other reasons for not being able to join include having a large infection (abscess) near the fistula, certain bowel problems like narrowing or inflammation near the bottom, having taken steroid medication recently, or a history of certain cancers or problems with your immune system.

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.

  1. Are you 18 years or older?
  2. Do you have Crohn's disease diagnosed for at least 6 months?
  3. Did you participate in the ADICROHN-2 study?
  4. Do you have ano-perineal fistulas that haven't healed or have come back?
  5. Is your Crohn's disease generally mild or inactive?
  6. Are you able to use reliable contraception if needed?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive an injection of your specially prepared cells (SVF) directly into the fistula area. You will already have had these cells taken and prepared from your previous involvement in the ADICROHN-2 study.

The study is designed to follow your progress to see how well the treatment works and to check for any side effects. The exact number of visits and their timing will be explained by the study doctor. You'll have regular checks, which might include examinations of the fistula area. The total duration of your participation will depend on the study's follow-up plan, but the main treatment is a single injection. If you initially received a placebo in the ADICROHN-2 study and your fistulas haven't healed, you may also be offered this active treatment.

Potential risks and benefits

Participating in this study might offer the potential benefit of healing or improving your ano-perineal fistulas, especially if they haven't responded to other treatments. This could lead to a better quality of life. However, as with any medical procedure, there are potential risks. These could include pain, swelling, or infection at the injection site, or other side effects, although previous studies have shown this treatment to be generally safe. Your safety will be closely monitored throughout the study. Remember, joining a study is always your choice, and you have the right to withdraw at any time, for any reason, without affecting your usual medical care.

Locations (1)

  • APHM hopital NORD
    Verified postcode
    Marseille, France· Recruiting

Common questions

What is an ano-perineal fistula?

It's an abnormal tunnel or connection that can form near the bottom (anus and surrounding area) in people with Crohn's disease, sometimes causing pain, leakage, or infection.

What are 'cryopreserved autologous stromal vascular fraction' cells?

These are special healing cells taken from your own body fat, then frozen (cryopreserved) for later use. 'Autologous' means they come from you, removing the risk of rejection.

Why is this treatment given as an injection?

Injecting the cells directly into the fistula area helps them get to where they need to be to encourage healing.

What does 'refractory' mean in this context?

It means the fistulas haven't gotten better with the usual standard treatments doctors would try.

Will I know if I got the real treatment or a placebo in the ADICROHN-2 study?

To ensure accurate results, participants in this study who were also in ADICROHN-2 will still not be told what treatment they received in that previous study.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Tolerance of Local Administration of Cryopreserved Autologou…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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