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OpenTrials
Completed

NCT Number: NCT05742100

Darvadstrocel for Crohn's Fistula in the Realworld

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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Key information

Conditions

Crohn's Fistula Crohn Disease Digestive System Diseases Digestive System Fistula Fistula Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darvadstrocel

Drug

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

Primary outcomes

  1. Number of Participants with clinical remission

    Time frame: 6-month

    Clinical remission was defined as closure of all previously draining external openings treated with darvadstrocel, despite gentle finger compression

  2. Number of Participants with clinical response

    Time frame: 6-month

    Clinical response was defined as closure of ≥50% of previously draining external openings treated with darvadstrocel, despite gentle finger compression

  3. Number of Participants with clinical radiographic healing

    Time frame: 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

  4. Number of Participants with combined clinical-radiological response

    Time frame: 6-month

    Combined clinical-radiological response, a new concept, was used to describe patients who achieved both clinical remission and complete radiological healing.

Sponsors and collaborators

Lead sponsor

Dolores Herreros Marcos

Other

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2023
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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