NCT03466515

Stem Cells Treatment of Complex Crohn's Anal Fistula

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Fistula
• Crohn Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-03-15
• Last updated: 2021-02-01

Locations

1 site across 1 country: Denmark