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Stem Cells Treatment of Complex Crohn's Anal Fistula (fistula)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466515
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : February 1, 2021
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Karam Matlub Sørensen, University of Southern Denmark

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
Anal Fistula Crohn Disease Procedure: stem cells injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: pilot 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 : June 1, 2018
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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




Primary Outcome Measures :
  1. healing [ Time Frame: 6 months ]
    closure of the fistula with no secretions


Secondary Outcome Measures :
  1. recurrence [ Time Frame: 6 months ]
    recurrence of the fistula

  2. time to healing [ Time Frame: 6 months ]
    time required to healing of the fistula

  3. major adverse effects [ Time Frame: 6 months ]
    occurrence of infections, sepsis bleeding and allergy.

  4. radiological healing [ Time Frame: at 6 months ]
    Changes on MRI scanning

  5. functional outcome [ Time Frame: 6 months ]
    changes in Wexner incontinence score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466515


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Investigators
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Principal Investigator: Karam Matlub, MD University of Southern Denmark
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Responsible Party: Karam Matlub Sørensen, afdelingslæge, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03466515    
Other Study ID Numbers: S-20170140
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karam Matlub Sørensen, University of Southern Denmark:
stem cells therapy
Additional relevant MeSH terms:
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Crohn Disease
Rectal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases