NCT05210309

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Universidad de Zaragoza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Type	Name	Description
PROCEDURE	Stem Cell Therapy	Application of Darvadstrocel locally, after fistula tract curettage and internal opening closure.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-04-01
• Completion: 2022-04-30
• First posted: 2022-01-27
• Last updated: 2023-01-18

Locations

4 sites across 1 country: Spain