Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

NCT ID: NCT03904212

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2024-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adipose tissue injection

Patients will be treated with freshly harvested autologous adipose tissue

Group Type: ACTIVE_COMPARATOR

Adipose tissue injection

Intervention Type: PROCEDURE

Injection with freshly harvested autologous adipose tissue

Placebo

Patients will be treated with saline

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: PROCEDURE

injection with saline

Interventions

Adipose tissue injection

Injection with freshly harvested autologous adipose tissue

Intervention Type: PROCEDURE

saline

injection with saline

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Lilli Lundby

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lilli Lundby, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus N, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anders Dige, MD

Role: CONTACT

andedige@rm.dk

+45 5190 3619

Facility Contacts

Anders Dige, MD

Role: primary

andedige@rm.dk

+45 5190 3619

Lilli Lundby, MD

Role: backup

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Adiposetissue_CD_Fistula_RCT

Identifier Type: -

Identifier Source: org_study_id