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New treatment option for Crohn Disease (CD)
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
What this study is testing
What is injection of thawed SVF?
injection of thawed SVF is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for crohn disease (cd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (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...
- (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...
You likely can't join if
- (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...
- (6) Malignant tumors or a history of malignant tumors within the past 5 years.
See the full eligibility 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.
- (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...
- (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...
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.