Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the procedure has been sufficiently demonstrated and the Spanish Agency of Medication approved its application a few months ago. Being aware about the difficulties to a proper application and management of the stem cells the Spanish Stem Cell therapy group devised, in a joint activity with the Spanish Group GERM (Grupo Español de Rehabilitacion Multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. The objective is to get a homogeneous implementation in all hospitals in Spain that have being baked to use this biological therapy.
Study Type
OBSERVATIONAL
Enrollment
63
Application of Darvadstrocel locally, after fistula tract curettage and internal opening closure.
Hospital de Elche
Elche, Alicante, Spain
HOSPITAL Meixoeiro Vigo
Vigo, Pontevedra, Spain
Hospital Vall D´Hebron
Barcelona, Spain
Hospital La Fe
Valencia, Spain
Therapeutic Efficacy of Darvadstrocel-Clinical
Clinical closure of the Fistula
Time frame: 6 moths
Therapeutic Efficacy of Darvadstrocel-MRI
MRI imaging closure of the Fistula
Time frame: 6 moths
Quality of Life (QoL)
QoL according to dedicated questionnaire (EuroQoL 5D-3L)
Time frame: 6 moths
PATIENT REPORTED OUTCOMES (PROs)
A Dedicated self complementary questionnaire (PROMs)
Time frame: 6 moths
Efficiency
Cost-Effectiveness of the procedure
Time frame: 6 moths
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