Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03904212
Study type	Interventional
Source	University of Aarhus
Contact	Anders Dige, MD
Phone	+45 5190 3619
Email	andedige@rm.dk
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	March 27, 2019
Completion date	March 1, 2024

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