Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease
Launched by MEDICAL UNIVERSITY OF VIENNA · Apr 3, 2022
Trial Information
Current as of August 22, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Medical University Of Vienna
The Medical University of Vienna is a leading research institution dedicated to advancing healthcare through innovative clinical research and education. Renowned for its commitment to excellence in medical science, the university fosters interdisciplinary collaboration among researchers, clinicians, and academic professionals. Its clinical trials encompass a wide range of medical disciplines, aiming to develop cutting-edge therapies and improve patient outcomes. With state-of-the-art facilities and a strong emphasis on ethical standards, the Medical University of Vienna is at the forefront of transforming scientific discoveries into practical applications that enhance global health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vienna, , Austria
Patients applied
Trial Officials
Stefan Riss, Prof.MD
Study Chair
Medical University of Vienna, Head of Pelvic Floor Surgery
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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