NCT03904212

Brief Summary

This randomized and placebo controlled study investigates the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment. 140 CD patients will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Primary outcome measures are clinical healing 6 months after treatment evaluated by clinical examination and pelvic MRI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 5, 2019

Status Verified

March 1, 2019

Enrollment Period

2.9 years

First QC Date

April 3, 2019

Last Update Submit

April 3, 2019

Conditions

Crohn DiseasePerianal FistulasCell- and Tissue-Based TherapyTreatment

Outcome Measures

Primary Outcomes (1)

  • Complete clinical healing 6 months after treatment

    No visible external opening or palpabel internal opening, no symptoms in the form of secretion and pelvic MR with out sign of fluid tracts.

    6 months after treatment

Secondary Outcomes (5)

  • Clinical healing 3 months after treatment

    3 months after treatment

  • Partial healing 6 months after treatment

    6 months

  • Reduction in symptoms 3 months after treatment

    3 months

  • Reduction in symptoms 6 months after treatment

    6 months

  • Changes in inconsistency 6 months after treatment

    6 months

Study Arms (2)

Adipose tissue injection

ACTIVE COMPARATOR

Patients will be treated with freshly harvested autologous adipose tissue

Procedure: Adipose tissue injection

Placebo

PLACEBO COMPARATOR

Patients will be treated with saline

Procedure: saline

Interventions

Adipose tissue injectionPROCEDURE

Injection with freshly harvested autologous adipose tissue

Adipose tissue injection
salinePROCEDURE

injection with saline

Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Crohn´s Disease
  • Perianal fistula with out branching or cavities with one external and one internal opening, which due to the risk for development of incontinence is not suitable for lay-open procedure, meaning: 1) all anterior interspinchteric and low transpinchteric (involving\<1/3 of spinchter) in women 2) high interspinchteric fistulas 3) high transspinchteric (\>1/3 of sphincter), suprasphincteric and ekstrasphincteric fistulas 4) intersphincteric or low transsphincteric fistula in patients with fecal incontinence and/or fecal urge.
  • no or minimal luminal disease activity by colonoscopy \< 3 months before treatment defined by Simple Endoscopic Severity for Crohn´s Disease\<3
  • Prior optimal medical treatment for fistulas (immunmodulators, antibiotics and/or anti-TNF-alfa treatment) with out achieving fistula healing
  • Treatment with seton for a minimum of 6 weeks
  • Speaks and understand Danish

You may not qualify if:

  • Pregnancy
  • Changes in immunmodulator or anti-TNFalfa treatment \< 12 weeks
  • Anovaginal fistulas
  • Rectal or anal stenosis
  • Active proctitis
  • Stoma
  • Previous surgery for fistulas besides simpel drainage or seton
  • Smoker
  • Insulin-dependent diabetes, conditions inducing defective immunity, pelvic radiation
  • pelvic MRI contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Lilli Lundby, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Dige, MD

CONTACT

+45 5190 3619andedige@rm.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 5, 2019

Study Start

March 27, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2024

Last Updated

April 5, 2019

Record last verified: 2019-03

Locations

DK(1)