NCT04834609

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

March 22, 2021

Last Update Submit

April 6, 2021

Conditions

Perianal FistulaAdipose TissueTissue Transplantation

Keywords

autologous adipose tissue, mesenchymal stem cells, perianal fistula

Outcome Measures

Primary Outcomes (4)

  • Investigation of cell proliferation of AT-MSCs

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

    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)

    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)

    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)

    At start of treatment

Secondary Outcomes (5)

  • Healing of anal fistula after treatment

    6 months after last injection of autologous adipose tissue

  • Evaluation of fistula healing after treatment

    6 months after last injection of autologous adipose tissue

  • Functional gastroenterological outcome after treatment

    6 months after last injection of autologous adipose tissue

  • Defecation disorder evaluation after treatment

    6 months after last injection of autologous adipose tissue

  • Functional urological outcome after treatment

    6 months after last injection of autologous adipose tissue

Study Arms (1)

Injection with adipose tissue

EXPERIMENTAL

Injection of freshly collected autologous adipose tissue

Procedure: Injection of autologous adipose tissue in anal fistula

Interventions

Injection of autologous adipose tissue in anal fistulaPROCEDURE
Injection with adipose tissue

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high trans-sphincteric fistulas
  • fistula confirmed and classified by an MRI.
  • seton (\> 6 weeks) prior to fat injection
  • informed, written consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34819138DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Characterisation of adipose tissue (AT-MSCs) was performed blinded to the result of the treatment responder/non-responder
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 8, 2021

Study Start

January 1, 2015

Primary Completion

October 1, 2017

Study Completion

February 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-03