Stem Cells Treatment of Complex Crohn`s Anal Fistula

Overview

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

Full Title of Study: “Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • healing
    • Time Frame: 6 months
    • closure of the fistula with no secretions

Secondary Measures

  • recurrence
    • Time Frame: 6 months
    • recurrence of the fistula
  • time to healing
    • Time Frame: 6 months
    • time required to healing of the fistula
  • major adverse effects
    • Time Frame: 6 months
    • occurrence of infections, sepsis bleeding and allergy.
  • radiological healing
    • Time Frame: at 6 months
    • Changes on MRI scanning
  • functional outcome
    • Time Frame: 6 months
    • changes in Wexner incontinence score

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Southern Denmark
  • Collaborator
    • Odense University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Karam Matlub Sørensen, afdelingslæge – University of Southern Denmark
  • Overall Official(s)
    • Karam Matlub, MD, Principal Investigator, University of Southern Denmark
  • Overall Contact(s)
    • Karam Matlub, MD, 004565415190, Karam.Faiq.Sorensen@rsyd.dk

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.