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

NCT05322057 | Completed DMC FDA Drug

• 1 other identifier: 1682/2018
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Fistula Perianal

Outcome Measures

Primary Outcomes (1)

• Fistula Closure

  The study's primary endpoint was established at week 52 with clinically assessed fistula closure.

  1 year

Secondary Outcomes (2)

• Evaluation of perianal disease

  1 year

• Evaluation of Crohn's disease

  1 year

Study Arms (1)

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

Interventions

Darvadstrocel DRUG

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

Also known as: Alofisel

patients with Crohn's disease and complex perianal fistula

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

14 patients with Crohn's disease and complex fistula got enrolled in this study.

You may qualify if:

• 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

You may not qualify if:

• rectovaginal fistulas
• rectal and/or anal stenosis
• active proctitis
• diverting stomas
• an abscess (\<2cm) that was not drained at the fistula preperation visit

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Stefan Riss, Prof.MD

  Medical University of Vienna, Head of Pelvic Floor Surgery

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. univ.

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: April 11, 2022
• Study Start: October 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)