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

Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study

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

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Anal Fistula
• Intervention / Treatment: Procedure: stem cells injection

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing	closure of the fistula with no secretions	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital
• Investigators: Principal Investigator: Karam Matlub, MD, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: stem cells therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Inflammatory Bowel Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Crohn Disease; Rectal Fistula
• Other Study ID Numbers: S-20170140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No