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

Completed

• Conditions: Fistula Perianal; Crohn Disease
• Interventions: Drug: Darvadstrocel

• Registration Number: NCT05322057
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-03
• Study First Submitted QC: 2022-04-03
• Last Update Submitted: 2022-04-03
• Study First Posted: 2022-04-11
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with Crohn's disease and complex perianal fistula	Darvadstrocel	14 patients with Crohn's disease refractory to standard treatment for complex perianal fistula got enrolled in this study.

Primary Outcome Measures

Name	Time	Method
Fistula Closure	1 year	The study's primary endpoint was established at week 52 with clinically assessed fistula closure.

Secondary Outcome Measures

Name	Time	Method
Evaluation of perianal disease	1 year	At every follow up visit the perianal disease was evaluated using the PDAI (Perianal disease activity index)
Evaluation of Crohn's disease	1 year	Crohn's disease was evaluated by using the HBI (Harvey Bradshaw Index)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria