Perianal FistulaNCT04834609
Adipose Derived Mesenchymal Stem Cell Characteristics in Anal Fistulas
A study testing Injection of autologous adipose tissue in anal fistula in people with Perianal Fistula and Adipose Tissue, run by University of Aarhus.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perianal Fistula, Adipose Tissue, Tissue Transplantation
- What is being tested?
- Injection of autologous adipose tissue in anal fistula
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high trans-sphincteric fistulas
- fistula confirmed and classified by an MRI.
- seton (> 6 weeks) prior to fat injection
- informed, written consent.
Who cannot join
- 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.
Show all 12Show fewer
- Pregnancy
- Psychiatric disorders
- BMI ≥ 35 or BMI<20
- Active tuberculosis
- Patient less than 18 years
- Unable to undergo MRI
About this study
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
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)
Read the 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
- Being tested
- Injection of autologous adipose tissue in anal fistula
- Keywords
- autologous adipose tissue, mesenchymal stem cells, perianal fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of autologous adipose tissue in anal fistulaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Injection with adipose tissue | Experimental | Injection of freshly collected autologous adipose tissue Receives: Procedure: Injection of autologous adipose tissue in anal fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of cell proliferation of AT-MSCs
Cell proliferation of AT-MSCs evaluated as number of cells/per day
Measured: At start of treatment
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)
Measured: At start of treatment
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)
Measured: At start of treatment
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)
Measured: At start of treatment
Secondary outcomes (5)
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 (%)
Measured: 6 months after last injection of autologous adipose tissue
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 (%)
Measured: 6 months after last injection of autologous adipose tissue
Functional gastroenterological outcome after treatment
Anal continence evaluated as the St. Mark's Score (0-24)
Measured: 6 months after last injection of autologous adipose tissue
Defecation disorder evaluation after treatment
Defecation disorders evaluated as Altomare Obstructed Defecation Score (0-31)
Measured: 6 months after last injection of autologous adipose tissue
Functional urological outcome after treatment
Urinary incontinence evaluated as ICIQ-UI-SF (0-21)
Measured: 6 months after last injection of autologous adipose tissue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study startJan 2015
- Primary completionOct 2017
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, UiT The Arctic University of Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834609
- Sponsor's protocol ID
- AT-MSCs_Anal fistulas
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34819138
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04834609
- Acronym / sponsor ID
- AT-MSCs_Anal fistulas
- Conditions
- Perianal Fistula, Adipose Tissue, Tissue Transplantation
- Keywords
- autologous adipose tissue, mesenchymal stem cells, perianal fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Southern Denmark, UiT The Arctic University of Norway
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection with adipose tissue | Experimental | Procedure: Injection of autologous adipose tissue in anal fistulaInjection of freshly collected autologous adipose tissue |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- high trans-sphincteric fistulas
- fistula confirmed and classified by an MRI.
- seton (> 6 weeks) prior to fat injection
- informed, written consent.
Key exclusion criteria (12 listed)
- Anovaginal fistula
- Active sepsis
- IBD, immunodeficiency, prior pelvic irradiation and malignancy
- Insulin dependent diabetes
- More than 4 prior attempts of fistula closure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of autologous adipose tissue in anal fistula | Procedure or surgery | Injection with adipose tissue |
Primary outcome
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
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)
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)
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)
5 secondary outcomes
Healing of anal fistula after treatment
Time frame: 6 months after last injection of autologous adipose tissue
Evaluation of fistula healing after treatment
Time frame: 6 months after last injection of autologous adipose tissue
Functional gastroenterological outcome after treatment
Time frame: 6 months after last injection of autologous adipose tissue
Defecation disorder evaluation after treatment
Time frame: 6 months after last injection of autologous adipose tissue
Functional urological outcome after treatment
Time frame: 6 months after last injection of autologous adipose tissue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 34819138Tencerova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of autologous adipose tissue in anal fistula in people with Perianal Fistula and Adipose Tissue, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of cell proliferation of AT-MSCs (time frame: At start of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.