Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

April 3, 2019 updated by: Lilli Lundby, University of Aarhus

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
        • Contact:
          • Lilli Lundby, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adipose tissue injection
Patients will be treated with freshly harvested autologous adipose tissue
Injection with freshly harvested autologous adipose tissue
Placebo Comparator: Placebo
Patients will be treated with 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
Time Frame: 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
Time Frame: 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
Time Frame: 6 months
Partial healing evaluated by pelvec MRI 6 months after treatment
6 months
Reduction in symptoms 3 months after treatment
Time Frame: 3 months
Change in Perianal Disease Activity Index (PDAI) 3 months after treatment
3 months
Reduction in symptoms 6 months after treatment
Time Frame: 6 months
Change in Perianal Disease Activity Index (PDAI) 6 months after treatment
6 months
Changes in inconsistency 6 months after treatment
Time Frame: 6 months
Change in inconsistency score (St.Marks) 6 months after treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lilli Lundby, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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