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Study of Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells and Microfat for Patients with Refractory Perianal Crohn's Disease Fistulas

Verified siteInvestigationalNo placebo
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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 treatment of , specifically targeting complex and difficult-to-treat perianal fistulas. The treatment being tested involves the use of , which are special cells taken from a patient's own fat tissue, combined with microfat. This combination is compared to a to see how effective it is in treating these fistulas.

The purpose of the study is to assess the effectiveness of this new treatment approach. Participants will receive local injections of either the cell therapy with microfat or a placebo. The study will monitor the progress over a period of 24 weeks to see if the treatment helps in closing the fistulas and improving the condition.

Throughout the study, participants will undergo regular check-ups, including scans, to evaluate the healing process and ensure there are no large fluid collections in the treated area. The study will also look at other factors like the reduction of symptoms and any side effects that may occur. The goal is to find a more effective way to manage and treat perianal fistulas in people with Crohn's disease.

The research process

The trial runs in 5 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 required to provide a signed informed consent. This confirms your understanding and agreement to participate in the trial.

    You must have been diagnosed with Crohn's Disease at least six months prior, and have one or more perianal fistulas that have not responded to previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted, which includes a clinical examination under anesthesia and an MRI to evaluate the fistulas.

    Your general health will be assessed through a physical examination and clinical history review.

  3. Step 3

    Treatment administration

    You will receive a local injection of either the study treatment or a placebo. The study treatment consists of autologous adipose tissue-derived stromal vascular fraction cells and microfat.

    The injection is administered as a suspension directly into the affected area.

  4. Step 4

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your progress. These visits will include clinical assessments and possibly additional MRIs to evaluate the treatment's effectiveness.

    The primary goal is to assess the closure of the fistula openings and ensure there are no significant fluid collections.

  5. Step 5

    Final assessment

    At week 24, a final assessment will be conducted to evaluate the treatment's success. This includes checking for the closure of fistula openings and confirming the absence of fluid collections via MRI.

    Additional evaluations will be performed to assess any changes in your quality of life and the severity of your Crohn's Disease symptoms.

Who can join the trial?

8 criteria

  • Signed informed consent: You must agree to participate in the study by signing a document that explains the study and your role in it.
  • Diagnosis of Crohn's Disease for at least 6 months: You must have been diagnosed with Crohn's Disease at least 6 months ago, based on medical tests and evaluations.
  • Presence of one or more refractory perianal fistula(s): You must have one or more fistulas, which are abnormal connections between the anal area and the skin, that have not responded to treatment. This will be checked by a doctor during an examination and an MRI scan.
  • Non-active or mildly active luminal Crohn's Disease: Your Crohn's Disease should not be very active, as measured by a score called CDAI, which should be 220 or less.
  • Age 18 years or older: You must be at least 18 years old to participate.
  • Good general health: You should be in good overall health based on your medical history and a physical examination by a doctor.
  • For women of childbearing age, a negative pregnancy test is required: Women who can have children must have a negative pregnancy test before joining the study. Both men and women must use effective birth control methods as advised by the study doctor.
  • Affiliation to a social security scheme: You must be part of a social security program.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a known allergy to any of the substances used in the study.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a condition that affects their immune system, making them more prone to infections.
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Investigated drugs

  • Autologous Adipose Derived Stromal Vascular Fraction (ADSVF)

    is a treatment that uses cells taken from your own body fat. These cells are thought to help heal and repair tissues. In this trial, ADSVF is injected locally to see if it can help treat complex perianal Crohn's fistulas, which are difficult to manage with standard treatments.

  • Microfat

    is a type of fat tissue that is processed to be used in medical treatments. It is taken from your own body and is used to help repair and regenerate tissues. In this trial, microfat is injected along with ADSVF to see if it can improve the healing of perianal Crohn's fistulas.

What is already known about the treatment

Autologous Adipose Derived Stromal Vascular Fraction (ADSVF) with Microfat – This treatment involves a local injection directly into the affected area, specifically targeting complex perianal fistulas in patients with Crohn's disease. Currently, this approach is being evaluated in clinical trials to determine its effectiveness compared to a placebo. The main therapeutic indication is for patients with Crohn's disease who have not responded to other treatments. At the molecular level, the ADSVF contains a variety of cells that can help reduce inflammation and promote healing. This treatment falls under the category of regenerative medicine, which uses the body's own cells to repair 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 inflammation can cause symptoms such as abdominal pain, diarrhea, and weight loss. The disease can lead to complications like strictures, fistulas, and malnutrition due to the inflammation and damage to the intestinal walls. Over time, the inflammation can penetrate deeper layers of the bowel, potentially leading to the formation of fistulas, which are abnormal connections between the intestine and other organs or tissues. The progression of Crohn's Disease is unpredictable, with some individuals experiencing mild symptoms and others facing severe 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 ID2024-517794-24-00Protocol codeADICROHN IIEstimated enrolment84 patientsSponsorAssistance Publique Hopitaux De Marseille

sourced from the EU Clinical Trials Register and site verification

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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).