Adipose Tissue in Crohn´s Disease Fistulas
Primary Purpose
Crohn Disease, Perianal Fistula, Tissue Transplantation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Injection with freshly collected autologous adipose tissue
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Fistulas developed following proctectomy were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
Injection with freshly collected autologous adipose tissue
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Ceased or reduced fistula secretion
Reported by the individual patient
Complications to the treatment
Reported by the individual patient and findings by clinical examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03803917
Brief Title
Adipose Tissue in Crohn´s Disease Fistulas
Official Title
Treatment of Perianal Fistulas in Crohn's Disease With Injection of Freshly Harvested Autologous Adipose Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (undefined)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lilli Lundby
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Investigators prospectively registered symptoms, complications and results of treatment in 21 patients with Crohn´s Disease who underwent treatment with freshly harvested autologous adipose tissue for perianal fistulas between March 2015 and June 2018. Inclusion criteria consisted of the following: the presence of complex CD fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment. Pelvic magnetic resonance imaging (MRI) was performed to describe the location and extent of the fistula. Clinical examinations of the patients were performed at intervals of six weeks, three months and six months following adipose tissue injection. Primary endpoint was complete fistula healing at clinical examination six months after the last injection. 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. Secondary endpoints included either reduced or ceased fistula secretion. If clinical healing of the fistula was not obtained six weeks after the first treatment, patients were offered a second adipose injection within two weeks. A third injection was offered to patients who did not have complete healing within six weeks of the first two injections.Pelvic MRI was repeated in all patients with transsphincteric and intersphincteric fistulas who, upon clinical examination, demonstrated complete healing at 6 months after the last injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Perianal Fistula, Tissue Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
Injection with freshly collected autologous adipose tissue
Intervention Type
Procedure
Intervention Name(s)
Injection with freshly collected autologous adipose tissue
Primary Outcome Measure Information:
Title
Clinical healing
Description
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
Time Frame
6 months after last injection
Secondary Outcome Measure Information:
Title
Ceased or reduced fistula secretion
Description
Reported by the individual patient
Time Frame
6 months after last injection
Title
Complications to the treatment
Description
Reported by the individual patient and findings by clinical examination
Time Frame
6 months after last injection
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- Fistulas developed following proctectomy were excluded.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30772343
Citation
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.
Results Reference
derived
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Adipose Tissue in Crohn´s Disease Fistulas
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