Crohn Disease Clinical Trial
Official title:
Treatment of Perianal Fistulas in Crohn's Disease With Injection of Freshly Harvested Autologous Adipose Tissue
Verified date | January 2019 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Present study investigated the efficacy of injection of freshly collected autologous adipose tissue into perianal fistulas in patients with Crohn's disease. Adipose tissue collected by liposuction was injected into the perianal fistulas. Primary objective was complete clinical healing six months after treatment. Secondary objectives were reduced or ceased fistula secretion and complications to the treatment.
Status | Completed |
Enrollment | 21 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of Crohn´s Disease - presence of complex Crohn´s Disease fistulas - fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment. Exclusion Criteria: - Fistulas developed following proctectomy were excluded. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lilli Lundby |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical healing | A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination | 6 months after last injection | |
Secondary | Ceased or reduced fistula secretion | Reported by the individual patient | 6 months after last injection | |
Secondary | Complications to the treatment | Reported by the individual patient and findings by clinical examination | 6 months after last injection |
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