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Completed

NCT Number: NCT05210309

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

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.

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Key information

Conditions

Safety Efficacy, Self

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Elche, Elche, Alicante, Spain

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Who can participate

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

Inclusion criteria

  • Adults aged 18 years or older who have complex perianal Crohn fistula
  • non-active or mildly active luminal Crohn's disease for at least 6 months.
  • The fistula had to have been draining for at least 6 weeks before inclusion.

Exclusion criteria

  • Patient with recto-vaginal fistula; rectal or anal stenosis; or active severe proctitis.

Treatment and study plan

Stem Cell Therapy

Procedure

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

Other names: Darvadstrocel

Primary outcomes

  1. Therapeutic Efficacy of Darvadstrocel-Clinical

    Time frame: 6 moths

    Clinical closure of the Fistula

  2. Therapeutic Efficacy of Darvadstrocel-MRI

    Time frame: 6 moths

    MRI imaging closure of the Fistula

Secondary outcomes

  1. Quality of Life (QoL)

    Time frame: 6 moths

    QoL according to dedicated questionnaire (EuroQoL 5D-3L)

  2. PATIENT REPORTED OUTCOMES (PROs)

    Time frame: 6 moths

    A Dedicated self complementary questionnaire (PROMs)

  3. Efficiency

    Time frame: 6 moths

    Cost-Effectiveness of the procedure

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Collaborators

  • Hospital Universitario Fundación Jiménez Díaz

Registry information

Acronym: PRIME

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
Jan 18, 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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