A Phase III multicenter, single blind, randomized, comparative, add?on clinical trial, in three parallel groups, to evaluate the efficacy and safety of a new therapy with adipose?derived autologous stem cells for the treatment of complex perianal fistulas in patients without inflammatory bowel disease FATT I: Fistula Advanced Therapy Trial (I) - FATT 1

CELLERIX, S.L.0 个研究点目标入组 207 人开始时间: 2007年10月24日最近更新: 2012年4月18日

适应症

试验速览

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•a.Patient with a complex perianal fistula amenable to local treatment with ASCs, as judged by the investigator after a clinical examination and MRI have been conducted.
•b.Patient of any sex aged 18 years or older
•c.Women of childbearing age should have a negative serum or urine pregnancy test and not be lactating before study entry. Both men and women should use adequate birth control methods as defined by the investigator.
•d.Seton presence is allowed at the time of study entry and until cells (in groups receiving ASCs) or fibrin adhesive are implanted.
•e.No condition that may prevent the patient from following the study procedures until 26 weeks of follow?up are completed is foreseen.
•f.Patient should give his/her signed, written informed consent.
•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 has been diagnosed with inflammatory bowel disease, as documented by radiology/endoscopy/histopathology.
•b.Patient has a rectovaginal fistula.
•c.Patient is a pregnant or lactating woman
•d.Patient has acute sepsis at the time of study entry
•e.A liposuction to draw al least 100 cc3 of fat from the abdominal wall is not technically feasible, or does not want this procedure to be performed.
•f.Patient needs surgery in the perianal region for reasons other than fistulas at the time of study entry, or is expected to possibly need any type of surgery in that area in the next 26 weeks. Abscess drainage is permitted.
•g.Presence of two or more complex perianal fistulas.
•h.Patient has collections >2 cm in MRI. If such collections exist, the patient may participate in the study if the investigating surgeon performs a complete toilette of the area, draining collections, and the absence of such collections or other collections >2 cm is shown in a subsequent MRI.
•i.Patient is allergic to local anesthetics or Gadolinium (MRI contrast agent)

发起方

CELLERIX, S.L.