MedTrace Logo

Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)

NCT03279081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2024-09-19

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (\>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

Conditions

Interventions

DRUG

Cx601

Cx601 eASCs intralesional injection.

OTHER

Placebo

Cx601 placebo-matching eASCs intralesional injection.

Sponsors & Collaborators

  • Tigenix S.A.U.

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2023-01-23
Completion
2023-07-26
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Puerto Rico
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03279081 on ClinicalTrials.gov