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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 December 2019
Main ID:  EUCTR2019-001948-21-FR
Date of registration: 15/05/2019
Prospective Registration: Yes
Primary sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Public title: 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.
Scientific title: 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. - ADICROHN-II
Date of first enrolment: 03/09/2019
Target sample size: 84
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001948-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
France
Contacts
Name: PROJECT MANAGER   
Address:  DRS 80 RUE BROCHIER 13354 MARSEILLE France
Telephone: 0491382747
Email: alexandra.giuliani@ap-hm.fr
Affiliation:  ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Name: PROJECT MANAGER   
Address:  DRS 80 RUE BROCHIER 13354 MARSEILLE France
Telephone: 0491382747
Email: alexandra.giuliani@ap-hm.fr
Affiliation:  ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Key inclusion & exclusion criteria
Inclusion criteria:
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

Exclusion criteria:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn’s disease
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Product Name: autologous ADIpose derived stromal vascular fraction
Product Code: ADSVF
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: vialebex 200mg
Product Name: VIALEBEX
Product Code: SERUM ALBUMINE 5%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ALBUMINE HUMAINE
Current Sponsor code: VIALEBEX
Other descriptive name: HUMAN ALBUMIN AS MACROAGGREGATES
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: serum physiologique 0.9 %
Product Name: chlorure de sodium
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: CHLORURE DE SODIUM
Other descriptive name: SODIUM CHLORIDE

Primary Outcome(s)
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).
Primary end point(s): efficacy
Secondary Objective: 1. Related to efficacy:
- 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
Timepoint(s) of evaluation of this end point: Weeks 52
Secondary Outcome(s)
Secondary end point(s): safety
Timepoint(s) of evaluation of this end point: weeks 52
Secondary ID(s)
2019-28
Source(s) of Monetary Support
ministery
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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