Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03904212
• Other study ID #: Adiposetissue_CD_Fistula_RCT
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 27, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2019
• Source: University of Aarhus
• Contact: Anders Dige, MD
• Phone: +45 5190 3619
• Email: andedige[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed with Crohn´s Disease

• Perianal fistula with out branching or cavities with one external and one internal opening, which due to the risk for development of incontinence is not suitable for lay-open procedure, meaning: 1) all anterior interspinchteric and low transpinchteric (involving<1/3 of spinchter) in women 2) high interspinchteric fistulas 3) high transspinchteric (>1/3 of sphincter), suprasphincteric and ekstrasphincteric fistulas 4) intersphincteric or low transsphincteric fistula in patients with fecal incontinence and/or fecal urge.

• no or minimal luminal disease activity by colonoscopy < 3 months before treatment defined by Simple Endoscopic Severity for Crohn´s Disease<3

• Prior optimal medical treatment for fistulas (immunmodulators, antibiotics and/or anti-TNF-alfa treatment) with out achieving fistula healing

• Treatment with seton for a minimum of 6 weeks

• Speaks and understand Danish

Exclusion Criteria:

• Pregnancy

• Changes in immunmodulator or anti-TNFalfa treatment < 12 weeks

• Anovaginal fistulas

• Rectal or anal stenosis

• Active proctitis

• Stoma

• Previous surgery for fistulas besides simpel drainage or seton

• Smoker

• Insulin-dependent diabetes, conditions inducing defective immunity, pelvic radiation

• pelvic MRI contraindicated

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Adipose tissue injection
Injection with freshly harvested autologous adipose tissue
• saline
injection with saline

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after treatment
Secondary	Clinical healing 3 months after treatment	o visible external opening or palpabel internal opening, no symptoms in the form of secretion	3 months after treatment
Secondary	Partial healing 6 months after treatment	Partial healing evaluated by pelvec MRI 6 months after treatment	6 months
Secondary	Reduction in symptoms 3 months after treatment	Change in Perianal Disease Activity Index (PDAI) 3 months after treatment	3 months
Secondary	Reduction in symptoms 6 months after treatment	Change in Perianal Disease Activity Index (PDAI) 6 months after treatment	6 months
Secondary	Changes in inconsistency 6 months after treatment	Change in inconsistency score (St.Marks) 6 months after treatment	6 months