Darvadstrocel for Crohn's Fistula in the Realworld

Completed

• Conditions: Crohn's Fistula
• Interventions: Drug: Darvadstrocel

• Registration Number: NCT05742100
• Lead Sponsor: Dolores Herreros Marcos

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2019-11-29
• Primary Completion: 2022-04-21
• Study Completion: 2022-04-21
• Status Verified: 2023-02
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-21
• Last Update Submitted: 2023-02-21
• Study First Posted: 2023-02-23
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• 1)complex fistula in a patient with CD
• 2)failure of conventional and anti-tumour necrosis factor treatment
• 3)absence of collection s>2cm confirmed by pelvic MRI scan at the time of surgery

Exclusion Criteria

• Patients with a diagnosis of rectovaginal fistula, rectal stenosis or severe active proctitis were excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group of patients treated with darvadstrocel	Darvadstrocel	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with combined clinical-radiological response	6-month	Combined clinical-radiological response, a new concept, was used to describe patients who achieved both clinical remission and complete radiological healing.
Number of Participants with clinical radiographic healing	6-month	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
Number of Participants with clinical remission	6-month	Clinical remission was defined as closure of all previously draining external openings treated with darvadstrocel, despite gentle finger compression
Number of Participants with clinical response	6-month	Clinical response was defined as closure of ≥50% of previously draining external openings treated with darvadstrocel, despite gentle finger compression

Trial Locations

Locations (1)

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain