EUCTR2008-004286-25-BE进行中（未招募）不适用
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
CELLERIX S.A.0 个研究点目标入组 196 人开始时间: 2008年9月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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) abscess before 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
- •administration.
- •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.
研究者
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