Stem Cells Treatment of Complex Crohn's Anal Fistula

Not Applicable

Completed

• Conditions: Anal Fistula; Crohn Disease
• Interventions: Procedure: stem cells injection

• Registration Number: NCT03466515
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-15
• Study Start: 2018-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	stem cells injection	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.

Primary Outcome Measures

Name	Time	Method
healing	6 months	closure of the fistula with no secretions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark