Adipose Tissue in Crohn´s Disease Fistulas
Treatment of Perianal Fistulas in Crohn's Disease With Injection of Freshly Harvested Autologous Adipose Tissue
1 other identifier
interventional
21
0 countries
N/A
Brief Summary
Present study investigated the efficacy of injection of freshly collected autologous adipose tissue into perianal fistulas in patients with Crohn's disease. Adipose tissue collected by liposuction was injected into the perianal fistulas. Primary objective was complete clinical healing six months after treatment. Secondary objectives were reduced or ceased fistula secretion and complications to the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
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 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedJanuary 15, 2019
January 1, 2019
3.3 years
January 8, 2019
January 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical healing
A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination
6 months after last injection
Secondary Outcomes (2)
Ceased or reduced fistula secretion
6 months after last injection
Complications to the treatment
6 months after last injection
Study Arms (1)
Treatment
OTHERInjection with freshly collected autologous adipose tissue
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Crohn´s Disease
- presence of complex Crohn´s Disease fistulas
- fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment.
You may not qualify if:
- \- Fistulas developed following proctectomy were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lilli Lundbylead
Related Publications (1)
Dige A, Hougaard HT, Agnholt J, Pedersen BG, Tencerova M, Kassem M, Krogh K, Lundby L. Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2019 Jun;156(8):2208-2216.e1. doi: 10.1053/j.gastro.2019.02.005. Epub 2019 Feb 14.
PMID: 30772343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 8, 2019
First Posted
January 15, 2019
Study Start
March 1, 2015
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
January 15, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share