Fat-derived stem cell injections for hard-to-treat anal fistulas in Crohn's disease
Tests injecting a person's own thawed fat-derived cells into fistulas from Crohn's disease.
Key facts
- Who runs it
- Assistance Publique Hopitaux De Marseille
- Where
- Marseille, FranceSee the site
- Trial code
- Registry title
- Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 25 people, planned
- Started
- 30 Dec 2025
- Expected to end
- 29 Jun 2028
- Type of study
- Interventional
- Treatments tested
- injection of thawed SVF
- Record updated
- 5 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease who took part in the ADICROHN-2 study and still have, or again have, anal or perineal fistulas. They would get an injection of their own stored fat-derived cells.
- Age
- Over 18 years
- Sex
- All
- Disease stage
- Crohn's disease diagnosed at least 6 months ago. Luminal disease not active or only mildly active (CDAI score ≤ 220). Anoperineal fistula(s) still present, or back after success in ADICROHN-2.
- Earlier treatment
- Must have been enrolled in or treated in the ADICROHN-2 study. Enough of their own stored (cryopreserved) cells must be available. No darvadstrocel in the last 6 months. No corticosteroids now or in the last four weeks.
Main reasons for not taking part
- Active Crohn's disease in the gut that needs treatment right away
- Intolerance to the cell treatment in ADICROHN-2
- Abscess or collection > 2 cm (0.8 in) at enrollment, unless it clears before treatment
- Cancer within the past 5 years, or any immunodeficiency
- BMI < 18 kg/m²
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- (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
Who cannot take part
- (2) Patients who experienced intolerance to the advanced therapy medicinal product during the ADICROHN-2 study
- (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
- (10) Treatment with darvadstrocel administered < 6 months prior to enrollment)
- (1) Active, primarily luminal Crohn's disease requiring immediate treatment
- (3) Presence of an abscess or collections > 2 cm at the time of enrollment, unless this issue is resolved during the fistula preparation period
- (6) Malignant tumors or a history of malignant tumors within the past 5 years
- (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
- (13) Coagulation disorders that contraindicate surgery
- (14) Known hypersensitivity to human albumin
- (7) Congenital or acquired immunodeficiency
- (8) Contraindications to local anesthetics and gadolinium (MRI contrast agent)
- (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
- (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 in France
- APHM - Hopital NordMarseille, FranceContact: Dr GUILLOTaking people
About the trial
What the trial wants to find out
The ADICROHN-3 study is a prospective, multicenter, open-label cohort study.
Read full original descriptionShow less
Its design is supported by the following elements:
* The results of the ADICROHN pilot study (EudraCT No. 2013-002602-31) and our 3-year study, which demonstrate an excellent safety profile with a promising efficacy signal. * Data from the literature confirming that cryopreservation of FVS does not compromise the clonogenic and differentiation potential of mesenchymal progenitors, nor its regenerative effect. * The ongoing ADICROHN-2 study (PHRC N 2019; EudraCT No. 2019-001948-21) confirming the feasibility of patient recruitment, mastery of the therapeutic approach, and the absence of adverse events related to the experimental treatment. * The opportunity for a second FVS injection for patients initially treated but who did not respond to the treatment. * The opportunity for a first FVS injection in patients in the placebo arm, thereby providing access to an innovative therapy available to patients included in this trial who are untreated and remain refractory to standard care.
To avoid compromising the results of the ongoing ADICROHN-2 study, enrolled patients will remain blinded to the treatment arm to which they belonged in the ADICROHN-2 study.
The group in the trial
- treatment armTreatment being tested
injection of thawed SVF
Treatment: injection of thawed SVF
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease
- Plain-language title
- Fat-derived stem cell injections for hard-to-treat anal fistulas in Crohn's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 June 2026