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Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03904212
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Lilli Lundby, University of Aarhus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn Disease Perianal Fistulas Cell- and Tissue-Based Therapy Treatment Procedure: Adipose tissue injection Procedure: saline Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Perianal Fistulas in Crohn´s Disease Patients With Autologous Adipose Tissue Injection: A Randomized and Placebocontrolled Study
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Partial healing 6 months after treatment [ Time Frame: 6 months ]
    Partial healing evaluated by pelvec MRI 6 months after treatment

  3. Reduction in symptoms 3 months after treatment [ Time Frame: 3 months ]
    Change in Perianal Disease Activity Index (PDAI) 3 months after treatment

  4. Reduction in symptoms 6 months after treatment [ Time Frame: 6 months ]
    Change in Perianal Disease Activity Index (PDAI) 6 months after treatment

  5. Changes in inconsistency 6 months after treatment [ Time Frame: 6 months ]
    Change in inconsistency score (St.Marks) 6 months after treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904212


Contacts
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Contact: Anders Dige, MD +45 5190 3619 andedige@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Anders Dige, MD    +45 5190 3619    andedige@rm.dk   
Contact: Lilli Lundby, MD         
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Lilli Lundby, MD Aarhus University Hospital
  Study Documents (Full-Text)

Documents provided by Lilli Lundby, University of Aarhus:
Study Protocol and Statistical Analysis Plan  [PDF] April 1, 2019

More Information
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Responsible Party: Lilli Lundby, MD PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT03904212    
Other Study ID Numbers: Adiposetissue_CD_Fistula_RCT
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Rectal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases