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Study on the Safety of Using Autologous Stromal Vascular Fraction Cells and Micrograft for Treating Hard-to-Heal Ano-Perineal Fistulas in Crohn's Disease Patients

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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 Crohn's disease, a chronic inflammatory condition that affects the digestive tract. The study is investigating a new treatment approach for a specific complication of Crohn's disease known as refractory ano-perineal fistulas. These are abnormal connections that can form between the end of the bowel and the skin near the anus, which can be difficult to treat. The treatment being tested involves the use of autologous adipose tissue-derived stromal vascular fraction cells, which are cells taken from a patient's own fat tissue. These cells are combined with a small amount of the patient's own fat, known as micrograft, and then injected into the affected area.

The purpose of the study is to evaluate the safety of this treatment method. Participants will receive the treatment and be monitored over a period of six months. During this time, they will have regular check-ups to assess for any signs of infection or other complications. The study will also look at how well the treatment works in closing the fistulas and improving the participants' quality of life. Assessments will be conducted at various intervals, including one week, one month, three months, and six months after the treatment is administered.

Throughout the study, participants will undergo evaluations using different methods, such as MRI scans, to check the healing progress of the fistulas. The study aims to provide valuable information on whether this innovative cell-based therapy can be a safe and effective option for individuals with Crohn's disease who have not responded to other treatments.

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 consent and eligibility

    Sign a consent form to confirm understanding and agreement to participate in the study.

    If applicable, women of childbearing age must take a pregnancy test to ensure a negative result.

    Ensure affiliation with a social security system.

    Confirm diagnosis of Crohn's disease for at least 6 months and meet specific health criteria.

  2. Step 2

    Treatment preparation

    Ensure availability of a sufficient quantity of cryopreserved cells for treatment, with at least 30 million frozen cells per fistula pathway.

  3. Step 3

    Treatment administration

    Receive an injection of cryopreserved autologous stromal vascular fraction cells combined with autologous microfat.

    The injection is administered as a suspension for injection using a solution supplemented with 0.5% human albumin.

  4. Step 4

    Follow-up visits

    Attend follow-up visits at 1 week, 1 month, 3 months, and 6 months after the treatment.

    During these visits, assessments will be conducted to monitor for any local or general infectious complications, changes in anal incontinence, and other potential adverse events.

  5. Step 5

    Evaluation of treatment response

    At each follow-up visit, the response to treatment will be evaluated, including the closure of the external opening of the fistula and the absence of significant fluid collection.

    Quality of life and disease activity will be assessed using specific questionnaires and indices.

  6. Step 6

    Final assessment

    At the 6-month mark, a comprehensive evaluation will be conducted to determine the overall safety and effectiveness of the treatment.

    This includes assessing the absence of complications and the degree of remission achieved.

Who can join the trial?

11 criteria

  • Sign a consent form to participate in the study.
  • Women of childbearing age must have a negative pregnancy test. This can be done with a blood or urine test. Both men and women should use reliable birth control methods.
  • Be part of a social security system.
  • Have been diagnosed with Crohn's disease at least 6 months ago. This diagnosis should be confirmed by clinical tests, endoscopy (a procedure to look inside the body), tissue samples, or imaging tests.
  • Have previously participated in the ADICROHN 2 study.
  • Have luminal non-active or weakly active Crohn's disease, which means having a CDAI score of 220 or less. The CDAI score is a way to measure the activity of Crohn's disease.
  • Have not responded to the ADICROHN-2 protocol, meaning the anoperineal fistula(s) (abnormal connections near the anus) are still present at the end of the ADICROHN-2 study and at the time of joining this study.
  • Have achieved combined remission at the end of the ADICROHN-2 study but have a recurrence of the anoperineal fistula(s) at the time of joining this study.
  • Have enough cryopreserved cells available for the treatment, with at least 30 million frozen cells per fistula pathway based on the number of fistulas to be treated.
  • Be over 18 years of age.
  • Be in good general health according to medical history and a physical examination.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who have had a recent infection or are currently experiencing an infection.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to any component of the treatment.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
  • Patients with a history of cancer, except for certain types of skin cancer.
  • Patients who have had a major surgery within the last 6 months.
  • Patients with a compromised immune system, which means their body has a reduced ability to fight infections and other diseases.
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Investigated drugs

  • Cryopreserved Autologous Stromal Vascular Fraction (VSF)

    is a treatment that uses a special type of cells taken from your own body. These cells are collected, processed, and then frozen to preserve them. In this trial, these cells are injected into the area around the fistulas, which are abnormal connections that can form in people with Crohn's disease. The goal is to help heal these fistulas by using your body's own cells to promote healing and reduce inflammation.

  • Autologous Microfat

    is a therapy that involves using small amounts of your own fat tissue. This fat is taken from your body, processed, and then injected into the area around the fistulas. The purpose of using your own fat is to help repair and regenerate the damaged tissue, potentially leading to the closure of the fistulas and improvement in symptoms.

What is already known about the treatment

Cryopreserved Autologous Stromal Vascular Fraction Combined with Micrograft – This treatment involves injecting a patient's own specially prepared cells and fat tissue to help heal difficult-to-treat fistulas in people with Crohn's disease. Currently, this approach is being studied to understand its safety and effectiveness, as it is not yet a standard treatment in medical practice. The main goal is to help close and heal the fistulas, which are abnormal connections that can form between the intestines and the skin. At the molecular level, the treatment is thought to work by using the body's own cells to promote healing and reduce inflammation in the affected area. This therapy falls under the category of regenerative medicine, which uses the body's own resources to repair and regenerate damaged tissues.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the ileum and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures, fistulas, and abscesses. Over time, the disease can cause damage to the digestive tract, potentially leading to further complications. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519740-32-00Protocol codeADICROHN IIIEstimated enrolment25 patientsSponsorAssistance Publique Hopitaux De Marseille

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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).