Adipose Tissue Injection in Perianal Fistulas in Crohn s Disease
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- STATUS
- Recruiting
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- End date
- Mar 1, 2024
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- participants needed
- 140
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- sponsor
- University of Aarhus
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 Identifier | NCT03904212 |
| Sponsor | University of Aarhus |
| Last Modified on | 22 January 2021 |
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