Crohn's Fistula
Conditions
Keywords
Adipose-derived stem cells, Cell therapy, Compassionate use, Crohn's disease, Fistula-in-ano
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.
Interventions
DRUGDarvadstrocel
expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas
Sponsors
Dolores Herreros Marcos
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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. |
Countries
Spain
Outcome results
None listed