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Completed

NCT Number: NCT04834609

Adipose Derived Mesenchymal Stem Cell Characteristics in Anal Fistulas

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)

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Key information

Conditions

Perianal Fistula Adipose Tissue Tissue Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of autologous adipose tissue in anal fistula

Procedure

Primary outcomes

  1. Investigation of cell proliferation of AT-MSCs

    Time frame: At start of treatment

    Cell proliferation of AT-MSCs evaluated as number of cells/per day

  2. Investigation of differentiation potential of AT-MSCs to differentiate into adipocyte

    Time frame: At start of treatment

    Differentiation potential of AT-MSCs: to differentiate into adipocyte measured by Oil-Red O staining and gene expression of adipogenic markers (PPARg and LPL normalized to housekeeping gene beta actin) presented as a Fold change to undifferentiated cells (arbitrary units)

  3. Investigation of differentiation potential of AT-MSCs to differentiate into osteoblast

    Time frame: At start of treatment

    Differentiation potential of AT-MSCs: to differentiate into osteoblast measured by Alizarin S staining and gene expression of osteogenic markers (BGALP and RUNX2 normalized to housekeeping gene beta actin) presented as a Fold change to undifferentiated cells (arbitrary units)

  4. Measurement of gene expression profile of AT-MSCs

    Time frame: At start of treatment

    Gene expression of proinflammatory (NFKB, TNFa, IL1B, IL6) and senescence associated molecules(CDKN2A, TP53, TGFB1, VEGFA, IFNG, IL6) of AT-MSCs in relation to the outcome of fistula treatment (i.e. comparison between responders and non-responders). The data are normalized to housekeeping gene beta actin (arbitrary units)

Secondary outcomes

  1. Healing of anal fistula after treatment

    Time frame: 6 months after last injection of autologous adipose tissue

    Clinical healing defined as closure of the internal and external fistula opening and no discharge evaluated as success rate of the healing in (%)

  2. Evaluation of fistula healing after treatment

    Time frame: 6 months after last injection of autologous adipose tissue

    A combination of Clinical and MRI healing defined as closure of the internal and external fistula opening and no discharge and no fluid filled fistula tracts on evaluated as success rate of the healing in (%)

  3. Functional gastroenterological outcome after treatment

    Time frame: 6 months after last injection of autologous adipose tissue

    Anal continence evaluated as the St. Mark's Score (0-24)

  4. Defecation disorder evaluation after treatment

    Time frame: 6 months after last injection of autologous adipose tissue

    Defecation disorders evaluated as Altomare Obstructed Defecation Score (0-31)

  5. Functional urological outcome after treatment

    Time frame: 6 months after last injection of autologous adipose tissue

    Urinary incontinence evaluated as ICIQ-UI-SF (0-21)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • UiT The Arctic University of Norway
  • University of Southern Denmark

Registry information

Official study title

Identification of Molecular Differences of Adipose-derived Mesenchymal Stem Cells Between Non- Responders and Responders in Treatment of Transsphincteric Perianal Fistulas Using Autologous Fat Graft Injection

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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