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Completed

NCT Number: NCT05322057

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Fistula Perianal Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darvadstrocel

Drug

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

Other names: Alofisel

Primary outcomes

  1. Fistula Closure

    Time frame: 1 year

    The study's primary endpoint was established at week 52 with clinically assessed fistula closure.

Secondary outcomes

  1. Evaluation of perianal disease

    Time frame: 1 year

    At every follow up visit the perianal disease was evaluated using the PDAI (Perianal disease activity index)

  2. Evaluation of Crohn's disease

    Time frame: 1 year

    Crohn's disease was evaluated by using the HBI (Harvey Bradshaw Index)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2022
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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