Cryopreserved autologous SVF plus micrograft for refractory ano-perineal fistulas in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, open-label study evaluating safety and potential efficacy of thawed autologous SVF injected locally with a micrograft to treat difficult ano-perineal fistulas in Crohn's disease. The study builds on prior ADICROHN work showing safety and signals of benefit, and it allows a second injection for non-responders as well as early access in the placebo arm. Eligible participants have Crohn's disease with persistent fistulas after previous ADICROHN-2 treatment and meet specific clinical criteria. The approach relies on cryopreserved cells to enable reuse and potential broader access if successful.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* (1) Signing of a consent form.
* (2) Patients with Crohn's disease diagnosed at least 6 months prior, in accordance with clinical, endoscopic, histological, and/or radiological criteria.
* (3) Patients previously enrolled in or treated as part of the ADICROHN 2 study.
* (4) Non-active or mildly active luminal Crohn's disease, defined by a CDAI score ≤ 220.
* (5) Patients who failed to respond to the ADICROHN-2 protocol, defined by the persistence of anoperineal fistula(s) at the end of the ADICROHN-2 study and their persistence at the time of enrollment.
* (6) Patients who achieved success (combined remission) at the end of the ADICROHN-2 study but who have a recurrence of anoperineal fistula(s) at the time of enrollment.
* (7) Sufficient quantity of cryopreserved cells to allow for the innovative treatment, based on the number of fistulas to be treated.
* (8) Patients over 18 years of age.
* (9) Good general health based on medical history and clinical examination.
* (10) Women of childbearing age must have a negative pregnancy test (serum or urine; detection threshold: 25 mIU hCG/ml). Patients of both sexes must use a reliable method of contraception.
* (11) Enrollment in a social security program.

Exclusion Criteria:

* (1) Active, primarily luminal Crohn's disease requiring immediate treatment.
* (2) Patients who experienced intolerance to the advanced therapy medicinal product during the ADICROHN-2 study.
* (3) Presence of an abscess or collections \> 2 cm at the time of enrollment, unless this issue is resolved during the fistula preparation period.
* (4) Rectal and/or anal stenosis and/or active proctitis resulting in a limitation of the surgical procedure.
* (5) Patients currently receiving corticosteroids or who have received them within the four weeks prior to the injection of the investigational product.
* (6) Malignant tumors or a history of malignant tumors within the past 5 years.
* (7) Congenital or acquired immunodeficiency.
* (8) Contraindications to local anesthetics and gadolinium (MRI contrast agent).
* (9) Contraindications to MRI: metallic foreign bodies (ferromagnetic material) and metallic implants (pacemakers, heart valves, vascular clips, surgical clips or staples, cochlear implants, any implanted electronic medical device or material \[e.g., insulin pump\], orthopedic medical prostheses.
* (10) Treatment with darvadstrocel administered \< 6 months prior to enrollment)
* (11) Contraindications to general anesthesia.
* (12) BMI \< 18 kg/m² to ensure an adequate amount of abdominal adipose tissue or other subcutaneous adipose tissue accessible via manual liposuction.
* (13) Coagulation disorders that contraindicate surgery.
* (14) Known hypersensitivity to human albumin.
* (15) Participation in another clinical trial (excluding observational studies).
* (16) Persons protected under Articles L1121-5, L1121-6, and L1121-8 of the Public Health Code (pregnant or breastfeeding women, persons deprived of liberty by judicial decision, persons in situations of social vulnerability, adults who are legally incapacitated or unable to give informed consent).

Where it's running

• APHM hopital NORD
  Marseille, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.