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National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)

NCT05210309 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2023-01-18

No results posted yet for this study

Summary

Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the procedure has been sufficiently demonstrated and the Spanish Agency of Medication approved its application a few months ago. Being aware about the difficulties to a proper application and management of the stem cells the Spanish Stem Cell therapy group devised, in a joint activity with the Spanish Group GERM (Grupo Español de Rehabilitacion Multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. The objective is to get a homogeneous implementation in all hospitals in Spain that have being baked to use this biological therapy.

Conditions

  • Safety
  • Efficacy, Self

Interventions

PROCEDURE

Stem Cell Therapy

Application of Darvadstrocel locally, after fistula tract curettage and internal opening closure.

Sponsors & Collaborators

  • Hospital Universitario Fundación Jiménez Díaz

    collaborator OTHER

  • Universidad de Zaragoza

    lead OTHER

Principal Investigators

  • Jose-M Ramirez, Prof · Catedra GERM Medicina Perioperatoria

  • Damian Garcia-Olmo, Prof · Fundación Jiménez Diaz. Madrid

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-04-01
Completion
2022-04-30

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 NCT05210309 on ClinicalTrials.gov