Adipose Derived Mesenchymal Stem Cell Characteristics in Anal Fistulas

Plain-language summary

This study examines the characteristics of mesenchymal stem cells derived from the patient's own adipose (fat) tissue in the treatment of high trans-sphincteric anal fistulas. It enrolled patients with an MRI-confirmed fistula who had a seton placed before the fat injection. It was conducted as a study without a phase designation and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Aarhus

Intervention

Injection of autologous adipose tissue in anal fistula

Start date

1/1/2015

Estimated completion

2/1/2021

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* high trans-sphincteric fistulas
* fistula confirmed and classified by an MRI.
* seton (\> 6 weeks) prior to fat injection
* informed, written consent.

Exclusion Criteria:

Anovaginal fistula

* Active sepsis
* IBD, immunodeficiency, prior pelvic irradiation and malignancy
* Insulin dependent diabetes
* More than 4 prior attempts of fistula closure
* Tobacco smoking or nicotine substitution 8 weeks prior to fat injection.
* Pregnancy
* Psychiatric disorders
* BMI ≥ 35 or BMI\<20
* Active tuberculosis
* Patient less than 18 years
* Unable to undergo MRI