Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Perianal Fistulas in Crohn´s Disease Patients With Autologous Adipose Tissue Injection: A Randomized and Placebocontrolled Study

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

Intervention / Treatment
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* Procedure: Adipose tissue injection
* Procedure: saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adipose tissue injection<br>Patients will be treated with freshly harvested autologous adipose tissue | Procedure: Adipose tissue injection<br>* Injection with freshly harvested autologous adipose tissue<br>|
| Placebo Comparator: Placebo<br>Patients will be treated with saline | Procedure: saline<br>* injection with saline<br>|

What is the study measuring?
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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 |