Stem Cells Treatment of Complex Crohn's Anal Fistula

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anal Fistula, Crohn Disease

Intervention / Treatment
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* Procedure: stem cells injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: pilot study with a maximum of 20 patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>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<br>* 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.<br>* Other names: fistula closure;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cells therapy