The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
Hospital Universitario La Paz
Madrid, Madrid, Spain
RECRUITINGSafety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae
Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound
Time frame: 16 weeks
Quality of life assessment using the SF-12 Questionnaire
Test SF-12 of quality of life
Time frame: 1, 4, 16,24 weeks
Adverse events
Control by investigation team of CRD (data collections)
Time frame: 1, 4, 12, 24 weeks
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