autologous adipose tissue-derived stromal vascular fraction cells for Crohn's disease

Inclusion criteria

• {"criterion_text":"- Signed informed consent\n- Patients with Crohn’s Disease (CD) diagnosed at least 6 months earlier in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria\n- Presence of one or more refractory perianal fistula(s) assessed by clinical assessment during examination under anaesthesia (preparation treatment) and MRI\n- Non-active or mildly active luminal CD defined as a CDAI ≤ 220\n- Patients of either sex aged 18 years or older\n- Good general state of health according to clinical history and a physical examination\n- For women of a childbearing age, they must have negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both men and women should use appropriate birth control methods defined by the investigator.\n- Affiliation to a social security scheme"}

Exclusion criteria

• {"criterion_text":"- Presence of dominant luminal active Crohn’s disease requiring immediate therapy\n- Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia)\n- Pregnant or breastfeeding women\n- Contraindication to the anaesthetic or surgical procedure\n- BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible by lipoharvest\n- Any active viral infection following: HIV, HTLV I and II, VHB, VHC and Syphillis\n- Bleeding disorders precluding surgical procedure\n- Patients with known hypersensitivity to human albumin\n- Participation in an another clinical trial\n- Adults without legal capacity\n- Patients in Health and Social Establishments\n- CDAI > 220\n- Persons in emergency situations\n- Persons deprived of their liberty\n- Non Affiliated to a social security scheme\n- Absence or refusal of the informed consent\n- Patient naïve to specific treatment for perianal fistulising Crohn’s disease\n- Presence of an abscess or collections > 2 cm, unless resolved in the preparation procedure\n- Rectal and/or anal stenosis, if this means a limitation for any surgical procedure\n- Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks\n- Malignant tumour or patients with a prior history of any malignant tumour, including any type of fistula carcinoma within 5 years prior to enrolment into this clinical study\n- Congenital or acquired immunodeficiencies\n- Contraindication to local anaesthetics or gadolinium (MRI contrast)"}

Primary endpoints

• {"endpoint_text":"- clinical assessment of closure (despite gentle finger compression) of all the external openings that were drained at baseline","definition_or_measurement_approach":"Clinical assessment of closure of all external openings that were draining at baseline (clinical exam), evaluated at week 24."}
• {"endpoint_text":"- MRI confirmation of absence of collections > 2 cm of the treated perianal fistulas at week 24","definition_or_measurement_approach":"MRI imaging evaluation at week 24 confirming absence of collections > 2 cm in the treated perianal fistulas."}

Secondary endpoints

• {"endpoint_text":"- assesment of complete cessation of suppuration","definition_or_measurement_approach":"Clinical assessment of complete cessation of suppuration (timepoints include W4, W12, W24 and W52 as per secondary objectives)."}
• {"endpoint_text":"- significant reduction of discharge","definition_or_measurement_approach":"Clinical assessment of reduction in discharge (timepoints W4, W12, W24 and W52)."}
• {"endpoint_text":"- clinical assessment of closure of all the external openings","definition_or_measurement_approach":"Clinical evaluation of closure of external openings (assessed at multiple timepoints W4, W12, W24 and W52)."}
• {"endpoint_text":"- severity of perianal Crohn’s disease (Perianal Disease Activity Index PDAI), improvement of Quality of Life Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (QoL), Crohn’s Disease Activity Index (CDAI), reduction of anal incontinence severity (Wexner score)","definition_or_measurement_approach":"Validated scales: PDAI, SIBDQ, CDAI and Wexner score assessments at W4, W12, W24 and W52."}
• {"endpoint_text":"- assessment of adverse events, severity, and causal relationship to study product","definition_or_measurement_approach":"Safety monitoring of adverse events with severity grading and investigator assessment of causal relationship to study product across study duration."}
• {"endpoint_text":"- assessment of quantification of regulatory lymphocyte subsets and soluble inflammatory molecules","definition_or_measurement_approach":"Laboratory quantification of regulatory lymphocyte subsets and soluble inflammatory molecules (blood) comparing W4 to baseline (D0)."}
• {"endpoint_text":"- cellular composition, secretory activity and transcriptional profile","definition_or_measurement_approach":"Characterization of ADSVF biological features (cellular composition, secretory activity and transcriptional profile) in treated patients."}
• {"endpoint_text":"- MRI charasteristics of fistula","definition_or_measurement_approach":"MRI characterization of fistula features at baseline and follow-up to identify predictors of response (baseline, W24 and W52)."}

France

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

520

Number Of Sites

4

Number Of Participants

84

Primary sponsor

Full Name

Centre Hospitalier Regional De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France