Last updated on August 2020

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)

Brief description of study

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.

Detailed Study Description

This study is to assess the efficacy and safety of Cx601, eASC, for the treatment of complex perianal fistulas in participants with Crohn's disease.

The study will randomize approximately 554 participants.

  • Cx601 eASCs intralesional injection
  • Placebo - Cx601 placebo-matching eASCs intralesional injection

Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS). The study will follow an add-on design, participants receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the CD will be allowed to continue it throughout the study.

The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both participant and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy.

This multicenter trial will be conducted globally across 150 centers. The overall time to participate in this study is approximately 5 years.

Clinical Study Identifier: NCT03279081

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Scottsdale Mayo Clinic

Scottsdale, AZ United States
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UC San Diego Health Systems

La Jolla, CA United States
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Kaiser Permamente

San Francisco, CA United States
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Cedar-Sinai Medical Center

West Hollywood, CA United States
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Mayo Clinic - Gastroenterology

Jacksonville, FL United States
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Florida Hospital Orlando

Orlando, FL United States
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Florida Hospital Tampa

Tampa, FL United States
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Cleveland Clinic Florida

Weston, FL United States
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Emory University

Atlanta, GA United States
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Northwestern University

Chicago, IL United States
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Carle Foundation Hospital

Urbana, IL United States
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University of Louisville

Louisville, KY United States
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University of Maryland

Baltimore, MD United States
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Lahey Hospital & Medical Center

Burlington, MA United States
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Boston Medical Center

Bridgewater, NJ United States
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Albany Medical Center

Albany, NY United States
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NYU Langone Medical Center

New York, NY United States
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Lenox Hill Hospital

New York, NY United States
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Cleveland Clinic

Cleveland, OH United States
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OHSU Digestive Health Center

Portland, OR United States
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Allegheny General Hospital

Pittsburgh, PA United States
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University of Utah

Salt Lake City, UT United States
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University of Virginia

Charlottesville, VA United States
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Swedish Medical Center

Seattle, WA United States
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Ottawa Hospital

Ottawa, ON Canada
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FN Hradec Kralove

Hradec Kralove, Czechia
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CHU de Nice

Nice Cedex 03, France
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CHU de Clermont-Ferrand - Estaing

Clermont-Ferrand cedex 1, France
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CHU Amiens-Picardie

AMIENS cedex 1, France
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Guys & St Thomas

London, United Kingdom
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Addenbrooke's Hospital

Cambridge, United Kingdom
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St. Mark's Hospital

Harrow, United Kingdom
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Northern General Hospital

Sheffield, United Kingdom
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Montreal, QC Canada
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CHU Saint Etienne

St Priest en Jarez, France
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Recruitment Status: Open

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