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 study about?

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.

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 treatment preparation

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

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Aavijpgtiu Podoyllb Hoyavlgx Du Mvgduyyhh	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2025

Trial locations

Investigated drugs:

Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells

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.

Investigated diseases:

Crohn's disease

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 ID:

2024-519740-32-00

Protocol code:

ADICROHN III

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?