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Completed
NCT05742100
Darvadstrocel for Crohn's Fistula in the Realworld
Conditions: Crohn's Fistula
Sex: All
Ages: 18 Years – N/A
Enrollment: 73
Sponsor: Dolores Herreros Marcos
Location: Spain
Summary
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.
Eligibility Criteria
Inclusion Criteria:1)complex fistula in a patient with CD2)failure of conventional and anti-tumour necrosis factor treatment3)absence of collection s>2cm confirmed by pelvic MRI scan at the time of surgeryExclusion Criteria:Patients with a diagnosis of rectovaginal fistula, rectal stenosis or severe active proctitis were excluded
Source: ClinicalTrials.gov (NCT05742100). StuddyBuddy aggregates publicly available trial information.