Adipose Tissue in Crohn´s Disease Fistulas

Not Applicable

Completed

• Conditions: Tissue Transplantation; Perianal Fistula; Crohn Disease
• Interventions: Procedure: Injection with freshly collected autologous adipose tissue

• Registration Number: NCT03803917
• Lead Sponsor: Lilli Lundby

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-03-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2019-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Injection with freshly collected autologous adipose tissue	Injection with freshly collected autologous adipose tissue

Primary Outcome Measures

Name	Time	Method
Clinical healing	6 months after 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 Outcome Measures

Name	Time	Method
Ceased or reduced fistula secretion	6 months after last injection	Reported by the individual patient
Complications to the treatment	6 months after last injection	Reported by the individual patient and findings by clinical examination