RecruitingPHASE1, PHASE2INTERVENTIONAL

Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula

This research is looking into a new treatment for perianal fistulas, a common and often painful problem for people with Crohn's disease. Standard treatments don't always work, and this study hopes to find a better solution. The treatment involves injecting special cells called AdMSC (CellReady®) into the fistulas. These cells are thought to help reduce inflammation and encourage healing. This is a Phase I/II study, meaning it's an early stage of testing to find a safe and effective dose, and to see how well it works for people whose fistulas haven't healed with other therapies. The study will test two different amounts of the cells to see which might be more effective.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University Hospital, Toulouse

Enrolment target

Start

12 Mar 2025

Estimated completion

01 Sep 2027

Crohn Disease

What is this study about?

If you have Crohn's disease, you might know that perianal fistulas can be a really challenging complication. These are small tunnels that can form near the anus and often cause pain, discomfort, and can sometimes lead to infections. While there are existing treatments, like drainage and certain medications, they don't work for everyone, and many people continue to struggle.

This study is exploring a new and innovative approach using something called AdMSC (CellReady®). These are special cells derived from fat tissue. Researchers believe these cells have properties that can help reduce inflammation, encourage new blood vessel growth, and promote healing in damaged tissues. The idea is that by injecting these cells directly into the fistula, they might help it to close and heal.

This particular study is in its early stages, known as Phase I/II. This means the main goals are to find out if the treatment is safe, and to work out the best dose to use. It will also look at how effective this cell therapy is for people whose perianal fistulas due to Crohn's haven't responded well to other treatments. The study will compare two different doses of the AdMSC cells to see which works best.

Key takeaways

This study is for adults with Crohn's disease and complex perianal fistulas that haven't healed with other treatments.
It uses special 'healing' cells (CellReady®) injected into the fistula.
The study aims to find a safe and effective dose of these cells.
It's an early-stage study to see if this new treatment can help reduce inflammation and encourage healing.
Two different doses of the cell treatment will be tested.

Who may be eligible?

To be able to join this study, you need to be an adult over 18 years old and registered with a social security system. You must have Crohn's disease that is generally well-managed in your intestines (your inner gut) and has been diagnosed for at least three months. Your recent colonoscopy, less than a year old, should not show any ulcers in your rectum.

Crucially, you must have a complex perianal fistula with a specific number of openings (no more than two inside and three outside) that hasn't healed despite at least six months of standard treatments, including drainage and certain anti-inflammatory medications. Your doctor will confirm if your condition matches these particular requirements.

There are also reasons why you might not be able to join. For example, if you've had cancer in the last five years, have certain types of infections, a transplanted organ, or allergies to specific medications used in the study. If you are pregnant or breastfeeding, or a woman of childbearing age not using effective contraception, you also cannot participate. You also can't join if you've previously been treated with a similar medication called ALOFISEL®.

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 or older?
Do you have Crohn's disease with a complex perianal fistula that hasn't healed after at least 6 months of standard treatment?
Is your Crohn's disease generally well-controlled in your main gut?
Have you not had cancer in the last 5 years or certain infections?
Are you not pregnant, breastfeeding, or a woman of childbearing age not using effective contraception?
Have you spoken with your doctor about your suitability for this type of research?

Answer every question to see your result.

What does participation involve?

If you choose to participate, you will receive injections of the AdMSC (CellReady®) cells directly into your fistula. There are two different doses of cells being tested, and you would receive one of these. The exact number of visits and the total duration aren't fully detailed here, but these details would be fully explained by the study team. You would have regular check-ups and assessments to monitor your health and how your fistula is responding to the treatment. This would involve medical examinations and possibly further imaging or tests. You can stop participating in the study at any time.

Potential risks and benefits

Participating in this study might offer a potential benefit if your Crohn's fistula hasn't responded to other treatments, as this new cell therapy could help with healing. However, as with any new treatment, there are potential risks, which will be fully explained by the study team. These could include side effects from the injections or the treatment itself. You have the right to withdraw from the study at any point, without affecting your usual medical care.

Locations (1)

Toulouse Hospital
Verified postcode
Toulouse, France· Recruiting

Common questions

What is a 'fistula'?

A fistula is a small, abnormal tunnel that connects two parts of your body, or a part of your body to the skin surface. Perianal fistulas connect the lower part of the bowel to the skin near the anus.

What are 'allogeneic adipose derived stroma/stem cells'?

These are special healing cells taken from fat tissue. 'Allogeneic' means they come from a donor, not from your own body.

Why are standard treatments not working for some people?

Perianal fistulas in Crohn's can be very stubborn. Even with drainage and strong medications, they sometimes fail to close or heal completely, leading to ongoing problems.

What does 'Phase I/II study' mean?

This means it's an early stage of clinical research. Phase I checks for safety and the best dose, and Phase II starts to see how well the treatment works.

Who is Cell-Easy?

Cell-Easy is a company that has developed this cell therapy, CellReady®, for potential use in treatments like this.

How to find out more

Etienne BUSCAIL, MD

buscail.e@chu-toulouse.fr 05 61 32 23 73 Official trial record

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