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

University of Zaragoza

Status: Completed

Conditions: Efficacy, Self; Safety

Treatments: Procedure: Stem Cell Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05210309

UZaragoza-1

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.