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Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

Primary Purpose

Crohn Disease, Perianal Fistulas, Cell- and Tissue-Based Therapy

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Adipose tissue injection
saline
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Adipose tissue injection

Placebo

Arm Description

Patients will be treated with freshly harvested autologous adipose tissue

Patients will be treated with saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2019
Last Updated
April 3, 2019
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03904212
Brief Title
Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease
Official Title
Treatment of Perianal Fistulas in Crohn´s Disease Patients With Autologous Adipose Tissue Injection: A Randomized and Placebocontrolled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Perianal Fistulas, Cell- and Tissue-Based Therapy, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adipose tissue injection
Arm Type
Active Comparator
Arm Description
Patients will be treated with freshly harvested autologous adipose tissue
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be treated with saline
Intervention Type
Procedure
Intervention Name(s)
Adipose tissue injection
Intervention Description
Injection with freshly harvested autologous adipose tissue
Intervention Type
Procedure
Intervention Name(s)
saline
Intervention Description
injection with saline
Primary Outcome Measure Information:
Title
Complete clinical healing 6 months after treatment
Description
No visible external opening or palpabel internal opening, no symptoms in the form of secretion and pelvic MR with out sign of fluid tracts.
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Clinical healing 3 months after treatment
Description
o visible external opening or palpabel internal opening, no symptoms in the form of secretion
Time Frame
3 months after treatment
Title
Partial healing 6 months after treatment
Description
Partial healing evaluated by pelvec MRI 6 months after treatment
Time Frame
6 months
Title
Reduction in symptoms 3 months after treatment
Description
Change in Perianal Disease Activity Index (PDAI) 3 months after treatment
Time Frame
3 months
Title
Reduction in symptoms 6 months after treatment
Description
Change in Perianal Disease Activity Index (PDAI) 6 months after treatment
Time Frame
6 months
Title
Changes in inconsistency 6 months after treatment
Description
Change in inconsistency score (St.Marks) 6 months after treatment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Dige, MD
Phone
+45 5190 3619
Email
andedige@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilli Lundby, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Dige, MD
Phone
+45 5190 3619
Email
andedige@rm.dk
First Name & Middle Initial & Last Name & Degree
Lilli Lundby, MD

12. IPD Sharing Statement

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Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

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