Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT07629245
Recruiting Phase 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

NCT07629245 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique Hopitaux De Marseille
Phase
Phase 1/2
Started
2025-12-30
Last updated
2026-06-05

Condition(s) studied

Crohn Disease (CD)

Investigational drug(s) / intervention(s)

injection of thawed SVF

injection of thawed SVF: injection of thawed SVF, collected in ADICROHN 2

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • The primary endpoint of the study is the overall safety profile at 6 months — 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 — 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 — 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 — 6 months
    absence of any other adverse events considered to be potentially related to the experimental treatment.

Trial sites (1)

FacilityCityRegionStatus
APHM hopital NORD Marseille France Recruiting

More Assistance Publique Hopitaux De Marseille trials in France

Application of ihMT MRI in Multiple Sclerosis Recruiting
PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV) Starting soon
Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis Starting soon
Assessment of Protein Intake Using 2 Types of Nutritional Collection in Chronic Kidney Disease. Recruiting
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis Recruiting

Other trials for the same condition

Kinetics of Transmural Healing in Patients With Crohns Disease Treated With Risankizumab (SKYRIZI®) Active, not recruiting
Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease. Recruiting
Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study Recruiting
Reliability of IUS in Crohn's Disease Recruiting
Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07629245 on ClinicalTrials.gov ↗ ← All trials in France