Anal Fistula, Crohn Disease
Conditions
Keywords
stem cells therapy
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.
Interventions
PROCEDUREstem 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.
Sponsors
Odense University Hospital
University of Southern Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
pilot study with a maximum of 20 patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| healing | 6 months | closure of the fistula with no secretions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence | 6 months | recurrence of the fistula |
| time to healing | 6 months | time required to healing of the fistula |
| major adverse effects | 6 months | occurrence of infections, sepsis bleeding and allergy. |
| radiological healing | at 6 months | Changes on MRI scanning |
| functional outcome | 6 months | changes in Wexner incontinence score |
Countries
Denmark
Outcome results
None listed