Darvadstrocel for Crohn's Fistula in the Realworld

NCT05742100 | Completed

• 1 other identifier: Darvastrocel Prime Study 001
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Background Perianal fistula may affect 15-50% of patients with Crohn's disease (CD). Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogeneic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European Medicines Agency and Spanish Agency of Medicines and Medical Products as a treatment for fistulas in CD. Recent European Crohn's and Colitis Organisation (ECCO) andSpanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) guidelines state that darvadstrocel is effective with a favourable safety profile,with a strong level of evidence (level 2).With this study we want to see the real efficacy of darvadstrocel in a Spanish population after 6 months of follow-up.

Conditions

Crohn's Fistula

Keywords

Adipose-derived stem cells; Cell therapy; Compassionate use; Crohn's disease; Fistula-in-ano

Outcome Measures

Primary Outcomes (4)

• Number of Participants with clinical remission

  Clinical remission was defined as closure of all previously draining external openings treated with darvadstrocel, despite gentle finger compression

  6-month

• Number of Participants with clinical response

  Clinical response was defined as closure of ≥50% of previously draining external openings treated with darvadstrocel, despite gentle finger compression

  6-month

• Number of Participants with clinical radiographic healing

  Complete radiographic healing was defined as an MRI result with no fluid collection \>2cm in all dimensions, no oedema and no inflammation nor sign of active inflammatory response;a remnant fistula tract scar may remain

  6-month

• Number of Participants with combined clinical-radiological response

  Combined clinical-radiological response, a new concept, was used to describe patients who achieved both clinical remission and complete radiological healing.

  6-month

Study Arms (1)

Group of patients treated with darvadstrocel

Drug: Darvadstrocel

Interventions

Darvadstrocel DRUG

expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas

Group of patients treated with darvadstrocel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with complex anorectal fistulas associated with CD treated with darvadstrocel in the 14 dedicated centres from 29 November 2019 to 21 April2022 will be enrolled in the study.

You may qualify if:

• )complex fistula in a patient with CD
• )failure of conventional and anti-tumour necrosis factor treatment
• )absence of collection s\>2cm confirmed by pelvic MRI scan at the time of surgery

You may not qualify if:

• Patients with a diagnosis of rectovaginal fistula, rectal stenosis or severe active proctitis were excluded

Sponsors & Collaborators

• Dolores Herreros Marcos: lead

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Related Publications (1)

• Herreros MD, Ramirez JM, Otero-Pineiro AM, Marti-Gallostra M, Badiola I, Enriquez-Navascues JM, Millan M, Barreiro EM, De La Portilla F, Suarez Alecha J, Garcia-Olmo D; National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study) Group. Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistulas in Real Clinical Practice: The National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study). Dis Colon Rectum. 2024 Jul 1;67(7):960-967. doi: 10.1097/DCR.0000000000003216. Epub 2024 Apr 11.

  PMID: 38603800 DERIVED

MeSH Terms

Conditions

Crohn Disease; Rectal Fistula

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Fistula; Digestive System Fistula; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dolores Herreros

  Hospital Fundación Jiménez Diaz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 23, 2023
• Study Start: November 29, 2019
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

ES (1)