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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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Ajevxhnbdl Pslxdcmg Hldtdygx Da Mlbdofrqa Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
17.02.2020

Trial locations

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.

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 ID:
2024-517794-24-00
Protocol code:
ADICROHN II
NCT ID:
NCT04010526
Trial Phase:
Therapeutic exploratory (Phase II)

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