Darvadstrocel for Crohn's Fistula in the Realworld

• Sponsor: Dolores Herreros Marcos (Other)
• Overall Status: Completed
• CT.gov ID: NCT05742100
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Actual Duration (Months): 28.7
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Fistula	Drug: Darvadstrocel

Detailed Description

Methods: The criteria for the Spanish National Health System to fund darvadstrocel treatment are: 1)complex fistula in a patient with CD; 2)failure of conventional and anti-tumour necrosis factor treatment; and 3)absence of collection s>2cm confirmed by pelvic MRI scan at the time of surgery. From November 2019 to April 2022, 73 patients were treated with darvadstrocel at 14Spanish centres and evaluated clinically and radiologically 6 months after treatment.

Study Design

• Study Type: Observational
• Actual Enrollment: 73 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistula in Real Clinical Practice: the National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)
• Actual Study Start Date: Nov 29, 2019
• Actual Primary Completion Date: Apr 21, 2022
• Actual Study Completion Date: Apr 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group of patients treated with darvadstrocel	Drug: Darvadstrocel; expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas

Outcome Measures

Primary Outcome Measures

1. Number of Participants with clinical remission [6-month]

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

2. Number of Participants with clinical response [6-month]

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

3. Number of Participants with clinical radiographic healing [6-month]

   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

4. Number of Participants with combined clinical-radiological response [6-month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1)complex fistula in a patient with CD

• 2)failure of conventional and anti-tumour necrosis factor treatment

• 3)absence of collection s>2cm confirmed by pelvic MRI scan at the time of surgery

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundacion Jimenez Diaz	Madrid		Spain	28040

Sponsors and Collaborators

• Dolores Herreros Marcos

Investigators

• Principal Investigator: Dolores Herreros, Hospital Fundación Jiménez Diaz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dolores Herreros Marcos, Principal Investigator, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• ClinicalTrials.gov Identifier: NCT05742100
• Other Study ID Numbers: Darvastrocel Prime Study 001
• First Posted: Feb 23, 2023
• Last Update Posted: Feb 23, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Dolores Herreros Marcos, Principal Investigator, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: Adipose-derived stem cells; Cell therapy; Compassionate use; Crohn's disease; Fistula-in-ano
• Additional relevant MeSH terms: Fistula

Study Results

No Results Posted as of Feb 23, 2023