Adipose Tissue Injection in Perianal Fistulas in Crohn s Disease

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    140
  • sponsor
    University of Aarhus
Updated on 22 January 2021

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.

Description

Injection with freshly harvested autologous adipose tissue has been reported to be an efficient treatment of perianal fistulas in patients with Crohns 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.

Details
Condition Therapeutic procedure, treatment, Inflammatory bowel disease, Inflammatory bowel disease, Crohn's Disease, Crohn's Disease, Crohn's Disease (Pediatric), Crohn's Disease (Pediatric), therapeutic technique, crohns disease, Perianal Fistulas, Cell- and Tissue-Based Therapy
Treatment Saline, Adipose tissue injection
Clinical Study IdentifierNCT03904212
SponsorUniversity of Aarhus
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with Crohns 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 Crohns 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
Clear my responses

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