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

Medical University of Vienna

Status: Completed

Conditions: Fistula Perianal; Crohn Disease

Treatments: Drug: Darvadstrocel

Study type: Observational

Funder types: Other

Identifiers

NCT05322057

1682/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

14 participants in 1 patient group

patients with Crohn's disease and complex perianal fistula

Description:

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

Treatment:

Drug: Darvadstrocel