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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05322057
Recruitment Status : Completed
First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Dawoud, Medical University of Vienna

Tracking Information
First Submitted Date April 3, 2022
First Posted Date April 11, 2022
Last Update Posted Date April 11, 2022
Actual Study Start Date October 1, 2018
Actual Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2022)		 Fistula Closure [ Time Frame: 1 year ]
The study's primary endpoint was established at week 52 with clinically assessed fistula closure.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 3, 2022)
  • 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)
  • Evaluation of Crohn's disease [ Time Frame: 1 year ]
    Crohn's disease was evaluated by using the HBI (Harvey Bradshaw Index)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease
Official Title Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease - a Prospective Nationwide Multicentre Study
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 14 patients with Crohn's disease and complex fistula got enrolled in this study.
Condition
  • Crohn Disease
  • Fistula Perianal
Intervention Drug: Darvadstrocel
Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract
Other Name: Alofisel
Study Groups/Cohorts patients with Crohn's disease and complex perianal fistula
14 patients with Crohn's disease refractory to standard treatment for complex perianal fistula got enrolled in this study.
Intervention: Drug: Darvadstrocel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2022)		 14
Original Actual Enrollment Same as current
Actual Study Completion Date December 1, 2021
Actual Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT05322057
Other Study ID Numbers 1682/2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: IPD can be shared just in anonymised form in case of an ethical agreement with other researches.
Current Responsible Party Dr. Christopher Dawoud, Medical University of Vienna
Original Responsible Party Same as current
Current Study Sponsor Medical University of Vienna
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Stefan Riss, Prof.MD Medical University of Vienna, Head of Pelvic Floor Surgery
PRS Account Medical University of Vienna
Verification Date April 2022