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

Completed

• Conditions: Efficacy, Self; Safety

• Registration Number: NCT05210309
• Lead Sponsor: Universidad de Zaragoza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic Efficacy of Darvadstrocel-MRI	6 moths	MRI imaging closure of the Fistula
Therapeutic Efficacy of Darvadstrocel-Clinical	6 moths	Clinical closure of the Fistula

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL)	6 moths	QoL according to dedicated questionnaire (EuroQoL 5D-3L)
Efficiency	6 moths	Cost-Effectiveness of the procedure
PATIENT REPORTED OUTCOMES (PROs)	6 moths	A Dedicated self complementary questionnaire (PROMs)

Trial Locations

Locations (4)

Hospital de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital Vall D´Hebron; 🇪🇸 Barcelona, Spain

HOSPITAL Meixoeiro Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain