Adipose Tissue in Crohn´s Disease Fistulas

Lilli Lundby

Status

Completed

Conditions

Perianal Fistula

Crohn Disease

Tissue Transplantation

Treatments

Procedure: Injection with freshly collected autologous adipose tissue

Study type

Interventional

Funder types

Other

Identifiers

NCT03803917

AT_ Fistula_observational

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Volunteers

No Healthy Volunteers

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