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

NCT05322057 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2022-04-11

No results posted yet for this study

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.

Conditions

  • Crohn Disease
  • Fistula Perianal

Interventions

DRUG

Darvadstrocel

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Stefan Riss, Prof.MD · Medical University of Vienna, Head of Pelvic Floor Surgery

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-12-01
Completion
2021-12-01
FDA Drug
Yes

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05322057 on ClinicalTrials.gov