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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Treatment; Perianal Fistulas; Cell- and Tissue-Based Therapy
• Intervention / Treatment: Procedure: Adipose tissue injection; Procedure: saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Anders Dige, MD; Phone Number: +45 5190 3619; Email: andedige@rm.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Anders Dige, MD; Phone Number: +45 5190 3619; Email: andedige@rm.dk
    • Contact: Lilli Lundby, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adipose tissue injection; Patients will be treated with freshly harvested autologous adipose tissue	Procedure: Adipose tissue injection; Injection with freshly harvested autologous adipose tissue
Placebo Comparator: Placebo; Patients will be treated with saline	Procedure: saline; injection with saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Partial healing 6 months after treatment	Partial healing evaluated by pelvec MRI 6 months after treatment	6 months
Reduction in symptoms 3 months after treatment	Change in Perianal Disease Activity Index (PDAI) 3 months after treatment	3 months
Reduction in symptoms 6 months after treatment	Change in Perianal Disease Activity Index (PDAI) 6 months after treatment	6 months
Changes in inconsistency 6 months after treatment	Change in inconsistency score (St.Marks) 6 months after treatment	6 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Lilli Lundby, MD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Inflammatory Bowel Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Crohn Disease; Rectal Fistula
• Other Study ID Numbers: Adiposetissue_CD_Fistula_RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No