Darvadstrocel for Crohn's Fistula in the Realworld

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-29

Study Completion Date

2022-04-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn's Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group of patients treated with darvadstrocel

Darvadstrocel

Intervention Type DRUG

expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas

Interventions

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Darvadstrocel

expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas

Intervention Type DRUG

Eligibility Criteria

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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