Clincosm LogoSign in Get a demo

fistula: Stem Cells Treatment of Complex Crohn's Anal Fistula

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03466515
Collaborator
Odense University Hospital (Other)
13
Enrollment
1
Location
1
Arm
31
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease.

Condition or Disease Intervention/Treatment Phase
  • Procedure: stem cells injection
 N/A

Detailed Description

Stem cells therapy in the management of soft tissue healing has been shown to be safe and feasible with encouraging short-term results both for crypto glandular and Crohns anal fistula. The long-term results are still insufficient but based on only a few studies conducted with small patient series and various techniques and type of stem cells. In the present study the patient's own adipose tissue derived regenerative cells (ADRCs) will be used. Traditionally the stem cells are injected into the fistula tract; however survival and retaining the stem cells in the fistula tract is problematic. Alternatively, one may apply stem cells enriched fatty tissue around and into the fistula tract. The aim of this project is to develop a method for treatment of patients with Crohns fistula. The results of conventional surgery are disappointing and followed by a high degree of recurrence and complications.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
pilot study with a maximum of 20 patientspilot study with a maximum of 20 patients
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention

Patients enrolled in the study will be treated for their anal fistula by surgical closure of the internal opening, debridement of the fistula and injection of patients own stem cells enriched fatty tissue around the fistula.

Procedure: stem cells injection
two surgical interventions as day-surgery, starting with liposuction from the abdomen (about 200-300 ml), and fistula tract debridement and closure of internal opening. The external opening is excised. About 30-40 ml fresh harvested patients own fatty tissue are then injected with large needle around the fistula from internal til external opening.The resting harvested fatty tissue will be sent to stem cells (Adipose Derived Regenrative Cells ADRCs) isolation, using Cytori Celusion system®. When the stem cells isolation is completed, 4ml concentrated stem cells ( contains around 20-40 millions cells ) will be injected around the prepared fistula tract, the same site where the fresh harvested fatty tissue injected before.
Other Names:
  • liposuction
  • fistula closure

    		•

    Outcome Measures

    Primary Outcome Measures

    1. healing [6 months]

      closure of the fistula with no secretions

    Secondary Outcome Measures

    1. recurrence [6 months]

      recurrence of the fistula

    2. time to healing [6 months]

      time required to healing of the fistula

    3. major adverse effects [6 months]

      occurrence of infections, sepsis bleeding and allergy.

    4. radiological healing [at 6 months]

      Changes on MRI scanning

    5. functional outcome [6 months]

      changes in Wexner incontinence score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with Crohn's anal fistulas and> 18 yrs old.
    Exclusion Criteria:

    • Signs of suppuration around the fistula

    • Active intestinal Crohn disease not in remission

    • Malignancy within 5 years

    • Previous radiotherapy of the abdomen and pelvis

    • BMI under 18.5

    • Coagulopathy

    • Fistula with side branches

    • Low anal fistula

    • Verified syphilis, HIV, or hepatitis on screening test.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense Denmark 5000

    Sponsors and Collaborators

    • University of Southern Denmark
    • Odense University Hospital

    Investigators

    • Principal Investigator: Karam Matlub, MD, University of Southern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karam Matlub Sørensen, afdelingslæge, University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT03466515
    Other Study ID Numbers:
    • S-20170140
    First Posted:
    Mar 15, 2018
    Last Update Posted:
    Feb 1, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Karam Matlub Sørensen, afdelingslæge, University of Southern Denmark
    stem cells therapy
    Additional relevant MeSH terms:
    Crohn Disease
    Rectal Fistula
    Fistula

    Study Results

    No Results Posted as of Feb 1, 2021