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 perianal Crohn?s disease. FATT II: Fistula Advanced Therapy Trial (II) - FATT II
- Conditions
- Complex perianal fistula in perianal Crohn´s diseaseMedDRA version: 9Level: LLTClassification code 10002156Term: Anal fistula
- Registration Number
- EUCTR2008-004286-25-NL
- Lead Sponsor
- CELLERIX S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 156
A patient can be included in the study if he/she meets ALL the criteria listed below:
1. Signed informed consent.
2. Subjects with Crohn?s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
3. Presence of complex perianal fistula with 3 or fewer fistulous tracts assessed by MRI.
4. Subjects with persistent and active complex perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
4.1. 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 (tracts) associated to a complex perianal fistula.
- Pain/fluctuation
5. Subjects of either sex aged over 18 years. Good general state of health according to the findings of the clinical history and the physical examination.
6. Women of a childbearing age with negative serum or urine pregnancy test (sensitive to 25 IU 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
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 luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy
2. Subjects with a CDAI ≥201.
3. Subjects with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start.
4. The presence of setons unless removed prior to treatment start.
5. Presence of >3 fistulous tracts and/or external openings.
6. Subjects with rectal and/or anal stenosis evaluated by rectoscopy or EUA.
7. Subjects who have received infliximab or any other anti-TNF agent in the 8 weeks before the cell treatment administration.
8. Subjects who have received tracrolimus or cicolporine in the 4 weeks before the cell treatment administration.
9. Subjects with rectovaginal fistula, anal fistula(s), and/or non-perianal enterocutaneous fistula.
10. Subjects with HIV, HBV, HCV or treponema infection, whether active or latent.
11. Subjects with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
12. Subjects with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or Subjects with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years.
13. Subjects with cardiopulmonary disease which, in the opinion of the investigator, is unstable or sufficiently serious to exclude the patient from the study.
14. Subjects with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from the study.
15. Subjects with congenital or acquired immunodeficiencies.
16. Subjects with abnormal laboratory test findings that contraindicate their inclusion in the study.
17. Subjects allergic to local anesthetics or gadolinium (MRI contrast).
18. MRI is unfeasible, (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. Subjects in need of surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or a need for such surgery is foreseen in this region in the 26 weeks after treatment administration.
21. Subjects who have suffered major surgery or severe trauma in the prior 6 months.
22. Pregnant or breastfeeding women.
23. Subjects who do not wish to or cannot comply with study procedures.
24. Subjects currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug.
25. Subjects unlikely to comply with study procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method