Perianal Fistula Clinical Trial
Official 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
Verified date | March 2021 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Aarhus | UiT The Arctic University of Norway, University of Southern Denmark |
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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