Adipose Derived Mesenchymal Stem Cell Characteristics in Anal Fistulas

NCT ID: NCT04834609

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2021-02-28

Brief Summary

This study investigated the cellular and molecular characteristics of AT-MSCs obtained from autologous AT therapy in patients with high transphincteric perianal fistulas of crytoglandular origin. Adipose tissue was injected into anal fistulas. Characteristics of adipose tissue mesenchymal stemcells (AT-MSC) was investigated and compared in patients with fistula that healed after the treatment (responders) to patients who failed to heal (non-responders)

Detailed Description

Injection with allogene or autologous stem cells has been reported to be efficient treatment of perianal fistulas. An alternative to this treatment could be injection with freshly collected autologous adipose tissue. In this study 27 patients with cryptoglandular anal fistulas were treated with freshly collected autologous adipose tissue.A clinical assessment of the patient prior to inclusion was undertaken and a loose seton placed for at least 6 weeks prior to fat injection. An MRI of the pelvis was performed before inclusion. Fistulas with secondary tracts and/or cavities were excluded. The operation was performed in one procedure including liposuction and injection of adipose tissue. A sample of adipose tissue from all 27 patients was analyzed. AT-MSCs were isolated and characterized using cellular and molecular analyses. Clinical and MRI-scanning evaluation of fistula healing and evaluation of ano-rectal function was performed after 6 months. AT-MSCs phenotype was compared between responders and non-responders with respect to fistula healing. The evaluation of the AT-MSCs was performed in a blinded manner.

Conditions

Perianal Fistula; Adipose Tissue; Tissue Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injection with adipose tissue

Injection of freshly collected autologous adipose tissue

Group Type: EXPERIMENTAL

Injection of autologous adipose tissue in anal fistula

Intervention Type: PROCEDURE

Interventions

Injection of autologous adipose tissue in anal fistula

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

UiT The Arctic University of Norway

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Tencerova M, Lundby L, Buntzen S, Norderval S, Hougaard HT, Pedersen BG, Kassem M. Molecular differences of adipose-derived mesenchymal stem cells between non-responders and responders in treatment of transphincteric perianal fistulas. Stem Cell Res Ther. 2021 Nov 24;12(1):586. doi: 10.1186/s13287-021-02644-8.

Reference Type: DERIVED

PMID: 34819138 (View on PubMed)

Other Identifiers

AT-MSCs_Anal fistulas

Identifier Type: -

Identifier Source: org_study_id