Darvadstrocel for Crohn's Fistula in the Realworld

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742100
• Other study ID #: Darvastrocel Prime Study 001
• Status: Completed
• Start date: November 29, 2019
• Est. completion date: April 21, 2022

Study information

• Verified date: February 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Crohn's Fistula
• Fistula

Intervention

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

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Diaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Dolores Herreros Marcos

Country where clinical trial is conducted

Spain, 

Outcome

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