Stem Cells Treatment of Complex Crohn's Anal Fistula

Crohn Disease Clinical Trial

— fistula  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466515
• Other study ID #: S-20170140
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Crohn Disease
• Fistula
• Rectal Fistula

Intervention

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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing	closure of the fistula with no secretions	6 months
Secondary	recurrence	recurrence of the fistula	6 months
Secondary	time to healing	time required to healing of the fistula	6 months
Secondary	major adverse effects	occurrence of infections, sepsis bleeding and allergy.	6 months
Secondary	radiological healing	Changes on MRI scanning	at 6 months
Secondary	functional outcome	changes in Wexner incontinence score	6 months