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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Safety Efficacy, Self

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Stem Cell Therapy

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

Intervention Type PROCEDURE

Other Intervention Names

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Darvadstrocel

Eligibility Criteria

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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.