The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.
Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601 - Darvadstrocel, Alofisel®) was performed in each patient. Closure of the external fistula opening without secretion by finger compression was defined as success.
Study Type
OBSERVATIONAL
Enrollment
14
Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract
Medical University of Vienna
Vienna, Austria
Fistula Closure
The study's primary endpoint was established at week 52 with clinically assessed fistula closure.
Time frame: 1 year
Evaluation of perianal disease
At every follow up visit the perianal disease was evaluated using the PDAI (Perianal disease activity index)
Time frame: 1 year
Evaluation of Crohn's disease
Crohn's disease was evaluated by using the HBI (Harvey Bradshaw Index)
Time frame: 1 year
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