Stem Cells Treatment of Complex Crohn's Anal Fistula (fistula)
Primary Purpose
Anal Fistula, Crohn Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
stem cells injection
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula focused on measuring stem cells therapy
Eligibility 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.
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
healing
closure of the fistula with no secretions
Secondary Outcome Measures
recurrence
recurrence of the fistula
time to healing
time required to healing of the fistula
major adverse effects
occurrence of infections, sepsis bleeding and allergy.
radiological healing
Changes on MRI scanning
functional outcome
changes in Wexner incontinence score
Full Information
NCT ID
NCT03466515
First Posted
March 8, 2018
Last Updated
January 29, 2021
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03466515
Brief Title
Stem Cells Treatment of Complex Crohn's Anal Fistula
Acronym
fistula
Official Title
Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula, Crohn Disease
Keywords
stem cells therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot study with a maximum of 20 patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
stem cells injection
Other Intervention Name(s)
liposuction, fistula closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
healing
Description
closure of the fistula with no secretions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
recurrence
Description
recurrence of the fistula
Time Frame
6 months
Title
time to healing
Description
time required to healing of the fistula
Time Frame
6 months
Title
major adverse effects
Description
occurrence of infections, sepsis bleeding and allergy.
Time Frame
6 months
Title
radiological healing
Description
Changes on MRI scanning
Time Frame
at 6 months
Title
functional outcome
Description
changes in Wexner incontinence score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karam Matlub, MD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stem Cells Treatment of Complex Crohn's Anal Fistula
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