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Study on the Effectiveness and Safety of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells for Treating Complex Perianal Fistulas in Children with Crohn's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Complex Perianal Fistulas in children and teenagers who have Crohn's Disease. Crohn's Disease is a long-term condition that causes inflammation in the digestive tract, and perianal fistulas are abnormal connections that can form near the anus, often causing pain and drainage. The treatment being tested in this study is called Darvadstrocel, which is a type of cell therapy made from special cells called allogeneic adipose tissue-derived mesenchymal stem cells. These cells are taken from healthy donors and are used to help heal the fistulas.

The purpose of the study is to evaluate how effective and safe Darvadstrocel is in treating these fistulas. Participants in the study will receive the treatment and be monitored over a period of 24 weeks, with an additional follow-up period extending up to 52 weeks. During this time, doctors will check if the fistulas are healing and if there are any side effects from the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the results.

The study aims to see if the treatment can help close the fistulas and reduce symptoms, improving the quality of life for those affected. The trial will involve regular check-ups and assessments, including the use of MRI scans to monitor the condition of the fistulas. The ultimate goal is to find a safe and effective treatment option for young patients dealing with this challenging aspect of Crohn's Disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to sign a consent form. This form confirms that you understand the study and agree to participate.

    If you are under 18, your parent or guardian will also need to sign the consent form.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests.

    The assessment will ensure that you have a diagnosis of Crohn's disease with complex perianal fistulas.

  3. Step 3

    Treatment administration

    You will receive the treatment called darvadstrocel, which is a suspension for injection containing allogeneic adipose tissue-derived mesenchymal stem cells.

    The treatment is administered through an injection directly into the fistula area.

  4. Step 4

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your progress. These visits will occur over a period of 24 weeks, with an extended follow-up for up to 52 weeks.

    During these visits, the closure of fistula openings and the absence of abscesses will be assessed.

  5. Step 5

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes checking vital signs and conducting laboratory tests.

    Any side effects or adverse events will be recorded and addressed by the study team.

  6. Step 6

    Completion of the study

    At the end of the study period, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

    You will be informed about the results and any further steps if necessary.

Who can join the trial?

9 criteria

  • The person must be able to understand and follow the study requirements, according to the study doctor.
  • The person, or their legal guardian, must sign a consent form before any study activities begin.
  • The person must be between the ages of 4 and under 18 at the time they receive the study treatment.
  • The person must have been diagnosed with Crohn's Disease (CD) at least 6 months before the study starts. This diagnosis should be based on medical tests like clinical exams, endoscopy, tissue samples, or imaging tests.
  • The person must have a complex perianal fistula that has not improved with at least one previous treatment, such as immunosuppressants or biologic medications (like anti-TNFs, anti-integrin, or anti-interleukin 12/23).
  • The complex perianal fistula must meet certain criteria, such as being in specific locations as shown by an MRI scan, having 2 or 3 external openings, or having fluid collections (abscesses) as shown by an MRI scan.
  • The person must have inactive or mildly active Crohn's Disease in the intestines.
  • If the person is a male who is not sterilized and is sexually active with a female partner who can become pregnant, he must agree to use a barrier method of birth control, like a condom, during the study. The female partner should also use a highly effective method of birth control.
  • If the person is a female who can become pregnant and is sexually active with a male partner who is not sterilized, she must agree to use a highly effective method of birth control during the study.

Who cannot join the trial?

9 criteria

  • Patients who are not between the ages of 4 and 17 years old.
  • Patients who do not have a condition called Complex Perianal Fistulas related to Crohn's Disease. A fistula is an abnormal connection between two body parts, and perianal means around the anus.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are taking certain medications that could affect the study results.
  • Patients who have had recent surgery or medical procedures that could impact the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have participated in another clinical trial recently.
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Investigated drugs

Darvadstrocel is a type of therapy that uses stem cells to help heal complex perianal fistulas, which are abnormal connections that can form between the end of the bowel and the skin near the anus. These fistulas can be particularly challenging to treat, especially in children with Crohn's Disease. The stem cells in darvadstrocel are designed to reduce inflammation and promote healing in the affected area. In this clinical trial, the goal is to see how well darvadstrocel works in helping these fistulas heal over a period of 24 weeks, with additional follow-up to ensure long-term effectiveness and safety.

What is already known about the treatment

Darvadstrocel – Darvadstrocel is administered as an injection directly into the affected area, specifically targeting complex perianal fistulas in patients with Crohn's Disease. It is currently being studied in clinical trials to assess its effectiveness and safety, particularly in pediatric patients. The main therapeutic use of darvadstrocel is to help heal these difficult-to-treat fistulas, which are abnormal connections that can form between the intestine and the skin near the anus. At the molecular level, darvadstrocel works by using stem cells to reduce inflammation and promote tissue repair in the affected area. It is classified pharmacologically as a cell therapy product.

Investigated diseases

Complex Perianal Fistulas in Crohn's Disease – Complex perianal fistulas are abnormal connections that form between the anal canal and the skin near the anus, often associated with Crohn's Disease. These fistulas can cause persistent drainage and discomfort. Over time, they may lead to complications such as infections or abscesses. The condition is characterized by multiple tracts and openings, making it difficult to heal naturally. The progression of these fistulas can vary, with some becoming more extensive or developing new branches. Management often focuses on reducing inflammation and promoting closure of the fistula tracts.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-503973-39-00Protocol codeDarvadstrocel-3004Estimated enrolment20 patientsSponsorTakeda Development Center Americas Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).