EUCTR2008-004286-25-NL进行中（未招募）1 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 perianal Crohn?s disease. FATT II: Fistula Advanced Therapy Trial (II) - FATT II
CELLERIX S.A.0 个研究点目标入组 156 人开始时间: 2008年8月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 156
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. 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
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 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.
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