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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05210309

Acronym

PRIME

Enrollment

Registered

2022-01-27

Start date

2020-01-01

Completion date

2022-04-30

Last updated

2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety, Efficacy, Self

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.

Interventions

PROCEDUREStem Cell Therapy

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Therapeutic Efficacy of Darvadstrocel-Clinical	6 moths	Clinical closure of the Fistula
Therapeutic Efficacy of Darvadstrocel-MRI	6 moths	MRI imaging closure of the Fistula

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026