Background Perianal fistula may affect 15-50% of patients with Crohn's disease (CD). Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogeneic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European Medicines Agency and Spanish Agency of Medicines and Medical Products as a treatment for fistulas in CD. Recent European Crohn's and Colitis Organisation (ECCO) andSpanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) guidelines state that darvadstrocel is effective with a favourable safety profile,with a strong level of evidence (level 2).With this study we want to see the real efficacy of darvadstrocel in a Spanish population after 6 months of follow-up.
Methods: The criteria for the Spanish National Health System to fund darvadstrocel treatment are: 1)complex fistula in a patient with CD; 2)failure of conventional and anti-tumour necrosis factor treatment; and 3)absence of collection s\>2cm confirmed by pelvic MRI scan at the time of surgery. From November 2019 to April 2022, 73 patients were treated with darvadstrocel at 14Spanish centres and evaluated clinically and radiologically 6 months after treatment.
Study Type
OBSERVATIONAL
Enrollment
73
expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas
Fundacion Jimenez Diaz
Madrid, Spain
Number of Participants with clinical remission
Clinical remission was defined as closure of all previously draining external openings treated with darvadstrocel, despite gentle finger compression
Time frame: 6-month
Number of Participants with clinical response
Clinical response was defined as closure of ≥50% of previously draining external openings treated with darvadstrocel, despite gentle finger compression
Time frame: 6-month
Number of Participants with clinical radiographic healing
Complete radiographic healing was defined as an MRI result with no fluid collection \>2cm in all dimensions, no oedema and no inflammation nor sign of active inflammatory response;a remnant fistula tract scar may remain
Time frame: 6-month
Number of Participants with combined clinical-radiological response
Combined clinical-radiological response, a new concept, was used to describe patients who achieved both clinical remission and complete radiological healing.
Time frame: 6-month
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