NL-OMON35164已完成3 期
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 II: Fistula Advanced Therapy Trial (II)
Cellerix S.A.0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
- •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 hCG). Both men and women should use appropriate birth control methods defined by the investigator.
排除标准
- •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 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, q-fever, 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.
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