NCT03904212

Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

Treatment of Perianal Fistulas in Crohn´s Disease Patients With Autologous Adipose Tissue Injection: A Randomized and Placebocontrolled Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Crohn Disease
• Perianal Fistulas
• Cell- and Tissue-Based Therapy
• Treatment

Interventions

Type	Name	Description
PROCEDURE	Adipose tissue injection	Injection with freshly harvested autologous adipose tissue
PROCEDURE	saline	injection with saline

Timeline

• Start date: 2019-03-27
• Primary completion: 2022-03-01
• Completion: 2024-03-01
• First posted: 2019-04-05
• Last updated: 2019-04-05

Locations

1 site across 1 country: Denmark