Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.FATT 2: Fistula Advanced Therapy Trial (II) - FATT II

• Conditions: Complex perianal fistula in perianal Crohn´s disease; MedDRA version: 9Level: LLTClassification code 10002156Term: Anal fistula

• Registration Number: EUCTR2008-004286-25-DE
• Lead Sponsor: CELLERIX S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

A patient can be included in the study if he/she meets ALL the criteria listed below:
1. Signed informed consent.
2. Patients with CD diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomical/topographical and/or radiologic criteria.
France and Italy only: Patients with CD diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomical/topographical and/or radiological criteria, unresponsive (treatment failure and/or intolerance and/or contraindication) to conventional treatment, including anti- TNF. Treatment failure means persistence or recurrence of fistula-related discharge despite correctly conducted induction treatment with anti-TNF antibodies with at least 3 infusions/injections. It is, however, possible to authorize inclusion of patients who do not tolerate anti-TNF antibodies (allergy) and, in consequence, have not received a complete course of anti-TNF antibody treatment. Patients to whom treatment with anti-TNF agent is contraindicated, may also be included if they fulfill other eligibility criteria.
3. Presence of complex perianal fistula with up to 3 external openings, assessed by MRI. The blinded fistulae branches visible though MRI are not considered fistula tracts but branches of the main tract. A complex perianal fistula is defined as a fistula that meets one or more of the following criteria:
- High fistulas (high inter-sphincteric, high trans-sphincteric, extra-sphincteric or
supra-sphincteric)
- Presence of 3 or fewer external openings associated to a complex perianal fistula.
4. Non-active or mildly active luminal CD defined by a CDAI =220.
5. Patients of either sex aged 18 years or older. Good general state of health according to clinical history and a physical examination.
6. Women of a childbearing age with 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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient cannot be included in the study if he/she meets ANY of the criteria listed below
1. Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active Crohns disease requiring immediate therapy, assessed by rectosigmoidoscopy
2. CDAI >220.
3. Presence of an abscess or collections >2 cm, unless a complete surgical debridement of the area has been performed, including drainage of the collection(s) and an MRI scan confirms absence of (residual) abscessbefore randomization.
4. Presence of setons. If present at screening they should be removed prior to treatment administration.
5. Presence of >3 external openings.
6. Rectal and/or anal stenosis.
7. Treatment with infliximab or any other anti-TNF agent in the 8 weeks before the cell
treatment administration.
8. Patients having received adalimumab in the 4 weeks before the cell treatment
adminsitration.
9. Treatment with tracrolimus or cyclosporine in the 4 weeks before the cell treatment
administration.
10. HIV, HBV, HCV or treponema infection.
11. Persistent chronic bacterial infections of temporary nature as well as local infections unless succesfully treated prior liposuction, such as syphilis, brucellosis, typhus, melioidosis, qfever, meningitis, or other.
12. Renal impairment defined by creatinine clearance below 60 ml/min calculated using
Cockcroft-Gault formula (see appendix I) or the following laboratory ranges:
Total bilirubin = 1.5 x upper limit of normal (ULN) AST and ALT =2.5 X ULN Serum creatinine =1.5 ULN
13. Known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
14. Malignant tumor or patients with a prior history of malignant tumors.
15. Current or recent history of abnormal, severe, progressive, uncontrolled liver function, anemia, hepatic, hematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric ,or cerebral disease.
16. Congenital or acquired immunodeficiencies.
17. Known allergies or hypersensivity to antibiotics including but not limited to penicillin, streptomycin, gentamicin, aminoglycosides; HSA; DMEM; materials of bovin origin; local anesthetics or gadolinium (MRI contrast).
18. Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia).
19. Liposuction with extraction of at least 100 cm3 of fat from the abdominal wall is technically unfeasible or the patient does not consent to the procedure.
20. Major surgery or severe trauma within the previous 6 months.
21. Pregnant or breastfeeding women.
22. Patients who do not wish to or cannot comply with study procedures.
23. Patients currently receiving, or having received within 3 months prior to enrolment into this clinical study, any investigational drug.
24. Patients unlikely to comply with study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified