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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

Study Description
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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.

Condition or disease Intervention/treatment
Crohn Disease Fistula Perianal Drug: Darvadstrocel

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 Design
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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease - a Prospective Nationwide Multicentre Study
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : December 1, 2021
Actual Study Completion Date : December 1, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Fistula Closure [ Time Frame: 1 year ]
    The study's primary endpoint was established at week 52 with clinically assessed fistula closure.


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
14 patients with Crohn's disease and complex fistula got enrolled in this study.
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05322057


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Chair: Stefan Riss, Prof.MD Medical University of Vienna, Head of Pelvic Floor Surgery
More Information
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Responsible Party: Dr. Christopher Dawoud, Dr. med. univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT05322057    
Other Study ID Numbers: 1682/2018
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (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.

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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
Additional relevant MeSH terms:
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Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical