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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05322057

Enrollment

Registered

2022-04-11

Start date

2018-10-01

Completion date

2021-12-01

Last updated

2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Fistula Perianal

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.

Interventions

DRUGDarvadstrocel

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026