Adipose Tissue in Crohn´s Disease Fistulas

Crohn Disease Clinical Trial

Official title:

Treatment of Perianal Fistulas in Crohn's Disease With Injection of Freshly Harvested Autologous Adipose Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803917
• Other study ID #: AT_ Fistula_observational
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Investigators prospectively registered symptoms, complications and results of treatment in 21 patients with Crohn´s Disease who underwent treatment with freshly harvested autologous adipose tissue for perianal fistulas between March 2015 and June 2018. Inclusion criteria consisted of the following: the presence of complex CD fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment. Pelvic magnetic resonance imaging (MRI) was performed to describe the location and extent of the fistula. Clinical examinations of the patients were performed at intervals of six weeks, three months and six months following adipose tissue injection. Primary endpoint was complete fistula healing at clinical examination six months after the last injection. 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. Secondary endpoints included either reduced or ceased fistula secretion. If clinical healing of the fistula was not obtained six weeks after the first treatment, patients were offered a second adipose injection within two weeks. A third injection was offered to patients who did not have complete healing within six weeks of the first two injections.Pelvic MRI was repeated in all patients with transsphincteric and intersphincteric fistulas who, upon clinical examination, demonstrated complete healing at 6 months after the last injection.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Crohn Disease
• Fistula
• Perianal Fistula
• Rectal Fistula
• Tissue Transplantation

Intervention

Procedure:
• Injection with freshly collected autologous adipose tissue

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lilli Lundby

Outcome

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