Clinical trial NCT05210309: National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)
Official title: National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety
Efficacy, Self
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Fundación Jiménez Díaz
First posted: 2022-01-27
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiens with perianal Crohn´s Disease who do not respond to current therapies.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic Efficacy of Darvadstrocel-Clinical
timeFrame: 6 moths
measure: Therapeutic Efficacy of Darvadstrocel-MRI
timeFrame: 6 moths
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: 6 moths
measure: PATIENT REPORTED OUTCOMES (PROs)
timeFrame: 6 moths
measure: Efficiency
timeFrame: 6 moths
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital de Elche
state: Alicante
city: Vigo
country: Spain
facility: HOSPITAL Meixoeiro Vigo
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Vall D´Hebron
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Catedra GERM Medicina Perioperatoria
name: Jose-M Ramirez, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Jiménez Diaz. Madrid
name: Damian Garcia-Olmo, Prof
role: STUDY_CHAIR
References:
citation: Scott LJ. Darvadstrocel: A Review in Treatment-Refractory Complex Perianal Fistulas in Crohn's Disease. BioDrugs. 2018 Dec;32(6):627-634. doi: 10.1007/s40259-018-0311-4.
citation: Panes J, Rimola J. Perianal fistulizing Crohn's disease: pathogenesis, diagnosis and therapy. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):652-664. doi: 10.1038/nrgastro.2017.104. Epub 2017 Aug 9.
citation: Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24.
citation: Garcia-Olmo D, Gilaberte I, Binek M, D Hoore AJL, Lindner D, Selvaggi F, Spinelli A, Panes J. Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn's Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial. Dis Colon Rectum. 2022 May 1;65(5):713-720. doi: 10.1097/DCR.0000000000002325.
citation: Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016 Sep 24;388(10051):1281-90. doi: 10.1016/S0140-6736(16)31203-X. Epub 2016 Jul 29.