- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904212
Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease
Treatment of Perianal Fistulas in Crohn´s Disease Patients With Autologous Adipose Tissue Injection: A Randomized and Placebocontrolled Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Anders Dige, MD
- Phone Number: +45 5190 3619
- Email: andedige@rm.dk
Study Locations
-
-
-
Aarhus N, Denmark, 8200
- Recruiting
- Aarhus University Hospital
-
Contact:
- Anders Dige, MD
- Phone Number: +45 5190 3619
- Email: andedige@rm.dk
-
Contact:
- Lilli Lundby, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Adipose tissue injection
Patients will be treated with freshly harvested autologous adipose tissue
|
Injection with freshly harvested autologous adipose tissue
|
Placebo Comparator: Placebo
Patients will be treated with saline
|
injection with saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months after treatment
|
Partial healing 6 months after treatment
Time Frame: 6 months
|
Partial healing evaluated by pelvec MRI 6 months after treatment
|
6 months
|
Reduction in symptoms 3 months after treatment
Time Frame: 3 months
|
Change in Perianal Disease Activity Index (PDAI) 3 months after treatment
|
3 months
|
Reduction in symptoms 6 months after treatment
Time Frame: 6 months
|
Change in Perianal Disease Activity Index (PDAI) 6 months after treatment
|
6 months
|
Changes in inconsistency 6 months after treatment
Time Frame: 6 months
|
Change in inconsistency score (St.Marks) 6 months after treatment
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lilli Lundby, MD, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adiposetissue_CD_Fistula_RCT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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