A Phase 2/3 interventional study of Adipose tissue injection and saline in Crohn Disease, Perianal Fistulas and Cell- and Tissue-Based Therapy, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by University of Aarhus · Phase 2/3, Interventional, and Treatment
This randomized and placebo controlled study investigates the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment. 140 CD patients will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Primary outcome measures are clinical healing 6 months after treatment evaluated by clinical examination and pelvic MRI.
Injection with freshly harvested autologous adipose tissue has been reported to be an efficient treatment of perianal fistulas in patients with Crohn´s Disease (CD). In a prospective observational study 57 % of 21 patients with complex fistulas refractory to combined surgical and/or medical treatment achieved complete clinical healing of the treated fistulas from one to three injections.
This randomized and placebo controlled study aims to confirm the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with perianal fistulas. 140 CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Clinical evaluation of the treatment efficacy will also be performed in a blinded manner.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 140 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Patients will be treated with freshly harvested autologous adipose tissue
Procedure: Adipose tissue injection
Patients will be treated with saline
Procedure: saline
Injection with freshly harvested autologous adipose tissue
injection with saline
Complete clinical healing 6 months after treatment
No visible external opening or palpabel internal opening, no symptoms in the form of secretion and pelvic MR with out sign of fluid tracts.
Time frame: 6 months after treatment
Clinical healing 3 months after treatment
o visible external opening or palpabel internal opening, no symptoms in the form of secretion
Time frame: 3 months after treatment
Partial healing 6 months after treatment
Partial healing evaluated by pelvec MRI 6 months after treatment
Time frame: 6 months
Reduction in symptoms 3 months after treatment
Change in Perianal Disease Activity Index (PDAI) 3 months after treatment
Time frame: 3 months
Reduction in symptoms 6 months after treatment
Change in Perianal Disease Activity Index (PDAI) 6 months after treatment
Time frame: 6 months
Changes in inconsistency 6 months after treatment
Change in inconsistency score (St.Marks) 6 months after treatment
Time frame: 6 months
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of Aarhus