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

NCT05210309 | Completed DMC

• 1 other identifier: UZaragoza-1
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 4

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.

Conditions

Safety; Efficacy, Self

Outcome Measures

Primary Outcomes (2)

• Therapeutic Efficacy of Darvadstrocel-Clinical

  Clinical closure of the Fistula

  6 moths

• Therapeutic Efficacy of Darvadstrocel-MRI

  MRI imaging closure of the Fistula

  6 moths

Secondary Outcomes (3)

• Quality of Life (QoL)

  6 moths

• PATIENT REPORTED OUTCOMES (PROs)

  6 moths

• Efficiency

  6 moths

Interventions

Stem Cell Therapy PROCEDURE

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

Also known as: Darvadstrocel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patiens with perianal Crohn´s Disease who do not respond to current therapies.

You may qualify if:

• 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.

You may not qualify if:

• Patient with recto-vaginal fistula; rectal or anal stenosis; or active severe proctitis.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Hospital Universitario Fundación Jiménez Díaz: collaborator

Study Sites (4)

Hospital de Elche

Elche, Alicante, Spain

Location

HOSPITAL Meixoeiro Vigo

Vigo, Pontevedra, Spain

Location

Hospital Vall D´Hebron

Barcelona, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Related Publications (5)

• 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.

  PMID: 30298387 BACKGROUND

• 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.

  PMID: 28790453 BACKGROUND

• 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.

  PMID: 29277560 BACKGROUND

• 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.

  PMID: 34890373 RESULT

• 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.

  PMID: 27477896 RESULT

Study Officials

• Jose-M Ramirez, Prof

  Catedra GERM Medicina Perioperatoria

  PRINCIPAL INVESTIGATOR

• Damian Garcia-Olmo, Prof

  Fundación Jiménez Diaz. Madrid

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 27, 2022
• Study Start: January 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)