Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas.
- Conditions
- Crohn’s diseaseTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-001948-21-FR
- Lead Sponsor
- ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 84
A patient will be included in the study if he/she meets ALL the following criteria:
(1) Signed informed consent
(2) Patients with Crohn’s Disease (CD) diagnosed at least 6 months earlier in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria
(3) Presence of one or more refractory perianal fistula(s) assessed by clinical assessment during examination under anaesthesia (preparation treatment) and MRI.
Refractory fistula is defined as failure of at least one surgical treatment (including drainage and seton placement) associated to anti TNF therapy. Failure of the anti-TNF is defined as no response 12 weeks after induction treatment was initiated, or after 12 weeks of maintenance treatment under stable dose.
(4) Non-active or mildly active luminal CD defined as a CDAI = 220
(5) Patients of either sex aged 18 years or older
(6) Good general state of health according to clinical history and a physical examination
(7) 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.
(8) Affiliation to a social security scheme
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
A patient will not be included in the study if he/she meets any of the following criteria:
(1) Presence of dominant luminal active Crohn’s disease requiring immediate therapy
(2) CDAI > 220
(3) Patient naïve to specific treatment for perianal fistulising Crohn’s disease
(4) Presence of an abscess or collections > 2 cm, unless resolved in the preparation procedure
(5) Rectal and/or anal stenosis, if this means a limitation for any surgical procedure
(6) Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks
(7) 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
(8) Congenital or acquired immunodeficiencies
(9) Contraindication to local anaesthetics or gadolinium (MRI contrast)
(10) Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia)
(11) Pregnant or breastfeeding women
(12) Contraindication to the anaesthetic or surgical procedure
(13) BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible by lipoharvest
(14) Any active viral infection following: HIV, HTLV I and II, VHB, VHC and Syphillis
(15) Bleeding disorders
(16) Patients with known hypersensitivity to human albumin
(17) Participation in an another clinical trial
(18) Adults without legal capacity
(19) Patients in Health and Social Establishments
(20) Persons in emergency situations
(21) Persons deprived of their liberty
(22) Non Affiliated to a social security scheme
(23) Absence or refusal of the informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to assess the efficacy of local injection of autologous ADSVF and microfat versus placebo for the treatment of complex refractory perianal Crohn’s fistulas at week 24 (W24).;Secondary Objective: 1.Related to efficacy: <br>- to assess the superiority of the autologous cellular treatment versus placebo on complete (defined by a complete cessation of suppuration) and partial (defined by significant reduction of discharge) response at W4, W12, W24, W52 <br>;Primary end point(s): efficacy;Timepoint(s) of evaluation of this end point: Weeks 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s): safety;Timepoint(s) of evaluation of this end point: weeks 52