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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04834609
Other study ID # AT-MSCs_Anal fistulas
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date February 2021

Study information

Verified date March 2021
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date February 2021
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
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

Study Design


Intervention

Procedure:
Injection of autologous adipose tissue in anal fistula


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus UiT The Arctic University of Norway, University of Southern Denmark

Outcome

Type Measure Description Time frame Safety issue
Primary Investigation of cell proliferation of AT-MSCs Cell proliferation of AT-MSCs evaluated as number of cells/per day At start of treatment
Primary Investigation of differentiation potential of AT-MSCs to differentiate into adipocyte 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) At start of treatment
Primary Investigation of differentiation potential of AT-MSCs to differentiate into osteoblast 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) At start of treatment
Primary Measurement of gene expression profile of AT-MSCs 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) At start of treatment
Secondary Healing of anal fistula after treatment Clinical healing defined as closure of the internal and external fistula opening and no discharge evaluated as success rate of the healing in (%) 6 months after last injection of autologous adipose tissue
Secondary Evaluation of fistula healing after treatment 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 (%) 6 months after last injection of autologous adipose tissue
Secondary Functional gastroenterological outcome after treatment Anal continence evaluated as the St. Mark's Score (0-24) 6 months after last injection of autologous adipose tissue
Secondary Defecation disorder evaluation after treatment Defecation disorders evaluated as Altomare Obstructed Defecation Score (0-31) 6 months after last injection of autologous adipose tissue
Secondary Functional urological outcome after treatment Urinary incontinence evaluated as ICIQ-UI-SF (0-21) 6 months after last injection of autologous adipose tissue
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