Cell- and Tissue-Based Therapy, Crohn Disease, Perianal Fistulas, Treatment
Conditions
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.
Interventions
PROCEDUREAdipose tissue injection
Injection with freshly harvested autologous adipose tissue
PROCEDUREsaline
injection with saline
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clinical healing 6 months after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical healing 3 months after treatment | 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 | 6 months | Partial healing evaluated by pelvec MRI 6 months after treatment |
| Reduction in symptoms 3 months after treatment | 3 months | Change in Perianal Disease Activity Index (PDAI) 3 months after treatment |
| Reduction in symptoms 6 months after treatment | 6 months | Change in Perianal Disease Activity Index (PDAI) 6 months after treatment |
| Changes in inconsistency 6 months after treatment | 6 months | Change in inconsistency score (St.Marks) 6 months after treatment |
Countries
Denmark
Contacts
Primary ContactAnders Dige, MD
Outcome results
None listed