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Study on the Long-Term Safety of Darvadstrocel for Adults with Crohn's Disease and Complex Perianal Fistulas

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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 the long-term safety of a treatment called Darvadstrocel for adults with Crohn's Disease who have a specific complication known as complex perianal fistula. A perianal fistula is an abnormal connection between the end of the bowel and the skin near the anus, which can cause discomfort and drainage. The treatment involves using a special type of cells called allogeneic adipose tissue-derived mesenchymal stem cells, which are expanded and prepared for injection. These cells are derived from fat tissue and are used to help heal the fistulas.

The purpose of the study is to evaluate the safety of giving this treatment more than once to patients who have already received it before. Participants in the study will receive a repeat administration of Darvadstrocel, and the study will monitor them over a long period to check for any side effects or complications. The study will also look at how well the treatment works in closing the fistulas and preventing them from reopening. This will be assessed at various points in time, such as 6 weeks, 24 weeks, and up to 156 weeks after the treatment is given again.

Throughout the study, participants will undergo regular check-ups and assessments, including MRI scans, to ensure the treatment is working effectively and to monitor for any new issues. The study aims to provide valuable information on the safety and effectiveness of using Darvadstrocel for treating complex perianal fistulas in people with Crohn's Disease, helping to improve future treatment options for this challenging condition.

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

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will confirm your eligibility based on specific criteria, such as your age, medical history, and current condition of your perianal fistula.

    You will be asked to sign a written informed consent form, which indicates your understanding and agreement to participate in the study.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to evaluate the current state of your condition. This may include a clinical assessment and a pelvic MRI scan to determine the characteristics of your perianal fistula.

    The assessment will help establish a starting point for measuring the effects of the treatment throughout the study.

  3. Step 3

    Treatment administration

    You will receive a treatment called darvadstrocel, which consists of a dispersion for injection containing allogeneic adipose tissue-derived mesenchymal stem cells.

    The treatment will be administered through an injection directly into the fistula area, known as intralesional use.

  4. Step 4

    Follow-up visits

    You will attend follow-up visits at specified intervals to monitor your response to the treatment. These visits will occur at weeks 6, 24, 52, 104, and 156 after the treatment administration.

    During these visits, healthcare professionals will assess the closure of fistula openings and check for any adverse effects or changes in your condition.

  5. Step 5

    Long-term monitoring

    The study aims to evaluate the long-term safety and effectiveness of the treatment. You will be monitored for any treatment-emergent adverse events, serious adverse events, and specific adverse events of special interest.

    Your condition will be assessed for any signs of relapse or new developments, such as the reopening of fistula openings or the formation of new abscesses.

  6. Step 6

    End of study

    The study is expected to conclude in September 2026. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes of the treatment.

    You will receive information about the results and any further recommendations for managing your condition.

Who can join the trial?

8 criteria

  • The subject must be capable of understanding and following the study requirements, according to the investigator's opinion.
  • The subject must sign and date a written informed consent form, which is a document that explains the study and confirms their agreement to participate.
  • The subject must be a male or female aged 18 years or older.
  • The subject must have complex perianal fistula(s), which are abnormal connections near the anus, with a maximum of 2 internal openings and 3 external openings. These must have been draining for at least 6 weeks before the start of the study. A complex perianal fistula is defined by certain criteria, such as its location or the presence of an associated abscess (a collection of pus).
  • The subject must have previously received treatment with darvadstrocel for a complex perianal fistula at least 6 months before the start of the study, and their doctor has planned another treatment for the same or a new fistula.
  • The subject must have controlled or mildly active Crohn's Disease (CD), which is a condition affecting the digestive system. This is measured by a specific score that should be less than 14.
  • If the subject is a non-sterilized male who is sexually active with a female partner who can become pregnant, he must agree to use a barrier method of contraception, like a condom, from the time of signing the consent form until 1 year after the repeat treatment.
  • If the subject is a female who can become pregnant and is sexually active with a non-sterilized male partner, she must agree to use a highly effective method of contraception from the time of signing the consent form until 1 year after the repeat treatment.

Who cannot join the trial?

8 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or planning to become pregnant during the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of allergic reactions to similar treatments.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have had a recent surgery related to their condition.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

Darvadstrocel is a type of therapy that uses stem cells to help treat complex perianal fistulas in patients with Crohn's Disease. These fistulas are abnormal connections that can form between the intestine and the skin near the anus, causing pain and discomfort. Darvadstrocel is designed to help close these fistulas and reduce symptoms by promoting healing in the affected area. In this clinical trial, the focus is on understanding how safe it is to use Darvadstrocel multiple times over a long period and how effective it is in treating these fistulas in the long term.

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 long-term safety and effectiveness when used repeatedly. The main therapeutic indication for darvadstrocel is to treat perianal fistulising Crohn's disease, a condition where abnormal connections form near the anus. At the molecular level, darvadstrocel works by using stem cells to reduce inflammation and promote healing in the affected tissues. It is classified pharmacologically as a cell therapy product.

Investigated diseases

Perianal fistulizing Crohn's disease – This condition is a complication of Crohn's disease, which is a chronic inflammatory bowel disease. It involves the formation of abnormal connections, called fistulas, between the perianal skin and the anal canal or rectum. These fistulas can cause persistent drainage and discomfort. Over time, they may lead to the development of abscesses, which are painful collections of pus. The disease can progress with periods of flare-ups and remission. The severity and frequency of symptoms can vary among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-503014-23-00Protocol codeAlofisel-4001Estimated enrolment53 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).