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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT05322057
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Actual Duration (Months): 38
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
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

• 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: Oct 1, 2018
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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 Names: Alofisel

Outcome Measures

Primary Outcome Measures

1. Fistula Closure [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 [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 [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Study Chair: Stefan Riss, Prof.MD, Medical University of Vienna, Head of Pelvic Floor Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Christopher Dawoud, Dr. med. univ., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05322057
• Other Study ID Numbers: 1682/2018
• First Posted: Apr 11, 2022
• Last Update Posted: Apr 11, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Crohn Disease; Fistula

Study Results

No Results Posted as of Apr 11, 2022