Darvadstrocel for Crohn's Fistula in the Realworld

Study Overview
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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.

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.

Official Title
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Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistula in Real Clinical Practice: the National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)

Conditions
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Crohn's Fistula

Intervention / Treatment
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* Drug: Darvadstrocel


Participation Criteria
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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 Exclusion Criteria: Patients with a diagnosis of rectovaginal fistula, rectal stenosis or severe active proctitis were excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group of patients treated with darvadstrocel<br> | Drug: Darvadstrocel<br>* expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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. | 6-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adipose-derived stem cells, Cell therapy, Compassionate use, Crohn's disease, Fistula-in-ano