Crohn's Fistula Clinical Trial
Official title:
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)
Verified date | February 2023 |
Source | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | April 21, 2022 |
Est. primary completion date | April 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Fundacion Jimenez Diaz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Dolores Herreros Marcos |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00992485 -
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
|
Phase 1 | |
Recruiting |
NCT04612465 -
Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
|
Phase 3 | |
Completed |
NCT01011244 -
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
|
Phase 2 |