Crohn Disease (CD)Phase 1/2ADICROHN3NCT07629245
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
A Phase 1/2 study testing injection of thawed SVF in people with Crohn Disease (CD), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The ADICROHN-3 study is a prospective, multicenter, open-label cohort study. 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- injection of thawed SVF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2025to 29 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
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- (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 join
- (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.
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- (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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
APHM hopital NORD
Marseille
Dr GUILLO, 0491968737 ext. +33, lucas.guillo@ap-hm.fr
About this study
The ADICROHN-3 study is a prospective, multicenter, open-label cohort study.
Its design is supported by the following elements:
Read more
- 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.
- Conditions
- Crohn Disease (CD)
- Being tested
- injection of thawed SVF
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of thawed SVFDrug
injection of thawed SVF, collected in ADICROHN 2
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | injection of thawed SVF Receives: Drug: injection of thawed SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is the overall safety profile at 6 months
absence of local infectious complications, defined by the absence of local signs of inflammation: pain, and/or erythematous plaque, and/or swelling or induration.
Measured: 6 months
The primary endpoint of the study is the overall safety profile at 6 months
absence of systemic infectious complications, defined as the absence of systemic signs of infection: fever, chills, mottling, hypotension.
Measured: 6 months
The primary endpoint of the study is the overall safety profile at 6 months
absence of any worsening of anal incontinence compared with the pre-treatment assessment, as measured by the Wexner index
Measured: 6 months
The primary endpoint of the study is the overall safety profile at 6 months
absence of any other adverse events considered to be potentially related to the experimental treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start30 Dec 2025
- Primary completion29 Jun 2028 (estimated)
- Study completion29 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629245
- Sponsor's protocol ID
- RCAPHM22_0449
- Other IDs
- 2024-519740-32-00
- Acronym
- ADICROHN3
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07629245
- Acronym / sponsor ID
- ADICROHN3 / RCAPHM22_0449
- Conditions
- Crohn Disease (CD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 29 Jun 2028 (estimated)
- Study completion
- 29 Jun 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ADICROHN-3 study is a prospective, multicenter, open-label cohort study.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: injection of thawed SVFinjection of thawed SVF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- (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.
Key exclusion criteria (16 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of thawed SVFinjection of thawed SVF, collected in ADICROHN 2 | Drug | treatment arm |
Primary outcome
The primary endpoint of the study is the overall safety profile at 6 months
Time frame: 6 months
absence of local infectious complications, defined by the absence of local signs of inflammation: pain, and/or erythematous plaque, and/or swelling or induration.
The primary endpoint of the study is the overall safety profile at 6 months
Time frame: 6 months
absence of systemic infectious complications, defined as the absence of systemic signs of infection: fever, chills, mottling, hypotension.
The primary endpoint of the study is the overall safety profile at 6 months
Time frame: 6 months
absence of any worsening of anal incontinence compared with the pre-treatment assessment, as measured by the Wexner index
The primary endpoint of the study is the overall safety profile at 6 months
Time frame: 6 months
absence of any other adverse events considered to be potentially related to the experimental treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing injection of thawed SVF in people with Crohn Disease (CD), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is the overall safety profile at 6 months (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.