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

University of Southern Denmark (SDU)

Status: Completed

Conditions: Anal Fistula; Crohn Disease

Treatments: Procedure: stem cells injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03466515

S-20170140

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

intervention

Experimental group

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.

Treatment:

Procedure: stem cells injection