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

Safety Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210309
• Other study ID #: UZaragoza-1
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2023
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 30, 2022
• Est. primary completion date: April 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18 years or older who have complex perianal Crohn ?stula

• non-active or mildly active luminal Crohn's disease for at least 6 months.

• The ?stula had to have been draining for at least 6 weeks before inclusion.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Efficacy, Self
• Fistula
• Safety

Intervention

Procedure:
• Stem Cell Therapy
Application of Darvadstrocel locally, after fistula tract curettage and internal opening closure.

Locations

Country	Name	City	State
Spain	Hospital Vall D´Hebron	Barcelona
Spain	Hospital de Elche	Elche	Alicante
Spain	Hospital La Fe	Valencia
Spain	HOSPITAL Meixoeiro Vigo	Vigo	Pontevedra

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Zaragoza	Hospital Universitario Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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 Di — View 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. — View 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 alloge — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Efficacy of Darvadstrocel-Clinical	Clinical closure of the Fistula	6 moths
Primary	Therapeutic Efficacy of Darvadstrocel-MRI	MRI imaging closure of the Fistula	6 moths
Secondary	Quality of Life (QoL)	QoL according to dedicated questionnaire (EuroQoL 5D-3L)	6 moths
Secondary	PATIENT REPORTED OUTCOMES (PROs)	A Dedicated self complementary questionnaire (PROMs)	6 moths
Secondary	Efficiency	Cost-Effectiveness of the procedure	6 moths