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Darvadstrocel for Crohn's Fistula in the Realworld

NCT05742100 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2023-02-23

No results posted yet for this study

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.

Conditions

  • Crohn's Fistula

Interventions

DRUG

Darvadstrocel

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

Sponsors & Collaborators

  • Dolores Herreros Marcos

    lead OTHER

Principal Investigators

  • Dolores Herreros · Hospital Fundación Jiménez Diaz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2022-04-21
Completion
2022-04-21

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05742100 on ClinicalTrials.gov