Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined … (NCT07629245) | Clinical Trial Compass
RecruitingPhase 1/2
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
France25 participantsStarted 2025-12-30
Plain-language 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.
* 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 collection…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary endpoint of the study is the overall safety profile at 6 months
Timeframe: 6 months
2
The primary endpoint of the study is the overall safety profile at 6 months
Timeframe: 6 months
3
The primary endpoint of the study is the overall safety profile at 6 months
Timeframe: 6 months
4
The primary endpoint of the study is the overall safety profile at 6 months