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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
Lilli Lundby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 8, 2019
    Last Updated
    January 10, 2019
    Sponsor
    Lilli Lundby
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    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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