Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease - a Prospective Nationwide Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322057
• Other study ID #: 1682/2018
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.

Description:

Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601 - Darvadstrocel, Alofisel®) was performed in each patient. Closure of the external fistula opening without secretion by finger compression was defined as success.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients aged 18 and older who had a non-active or mildly active luminal CD with complex fistula with a maximum of two internal and three external fistulas

Exclusion Criteria:

• rectovaginal fistulas

• rectal and/or anal stenosis

• active proctitis

• diverting stomas

• an abscess (<2cm) that was not drained at the fistula preperation visit

Related Conditions & MeSH terms

• Crohn Disease
• Fistula

Intervention

Drug:
• Darvadstrocel
Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula Closure	The study's primary endpoint was established at week 52 with clinically assessed fistula closure.	1 year
Secondary	Evaluation of perianal disease	At every follow up visit the perianal disease was evaluated using the PDAI (Perianal disease activity index)	1 year
Secondary	Evaluation of Crohn's disease	Crohn's disease was evaluated by using the HBI (Harvey Bradshaw Index)	1 year