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Completed Phase 3 Interventional Results available

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)

ClinicalTrials.gov ID: NCT03279081

Public ClinicalTrials.gov record NCT03279081. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 3:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre 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 Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks

Study identification

NCT ID
NCT03279081
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Tigenix S.A.U.
Industry
Enrollment
568 participants

Conditions and interventions

Interventions

  • Cx601 Drug
  • Placebo Other

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 14, 2017
Primary completion
Jan 22, 2023
Completion
Jul 25, 2023
Last update posted
Sep 18, 2024

2017 – 2023

United States locations

U.S. sites
68
U.S. states
32
U.S. cities
54
Facility City State ZIP Site status
Scottsdale Mayo Clinic Scottsdale Arizona 85259
UC San Diego Health Systems La Jolla California 92037
University of Southern California (USC) Norris Comprehensive Cancer Center Los Angeles California 90033
UC Irvine Medical Center - Chao Family Comprehensive Cancer Orange California 92868
Inland Empire Liver Foundation Rialto California 92377
Kaiser Permamente San Francisco California 91115
University of California San Francisco San Francisco California 94115
Vallejo Hospital and Medical Offices Vallejo California 94589
Cedar-Sinai Medical Center West Hollywood California 90048
University of Colorado Hospital Aurora Colorado 80045
Hartford Hospital - Gastroenterology Farmington Connecticut 06032
Yale University School of Medicine New Haven Connecticut 06519
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20017
Mayo Clinic - Gastroenterology Jacksonville Florida 32224
University of Miami Hospital Miami Florida 33136
Florida Hospital Orlando Orlando Florida 32804
USF Health South Tampa Center for Advanced Healthcare Tampa Florida 33606
Florida Hospital Tampa Tampa Florida 33613
Cleveland Clinic Florida Weston Florida 33331
Emory University Atlanta Georgia 30322
Northwestern University Chicago Illinois 60611
Rush University Medical Center Chicago Illinois 60612
The University of Chicago Medicine - Colon & Rectal Surgery Chicago Illinois 60637
Carle Foundation Hospital Urbana Illinois 61801
Indiana University - Colon and Rectal Indianapolis Indiana 46237
University of Kansas Sxchool of Medicine Kansas City Kansas 66160
University of Louisville Louisville Kentucky 40292
Digestive Health Center of Louisiana Baton Rouge Louisiana 70809
Colon and Rectal Surgery Associates Metairie Louisiana 70001
University Medical Center - New Orleans New Orleans Louisiana 71103
University of Maryland Baltimore Maryland 21201
Johns Hopkins Medicine - The Johns Hopkins Hospital Baltimore Maryland 21287
Massachussetts General Hospital Boston Massachusetts 02114
Boston Medical Center Boston Massachusetts 08807
Lahey Hospital & Medical Center Burlington Massachusetts 01803
University of Massachusetts - colon & rectal surgery Worcester Massachusetts 01605
Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery Rochester Minnesota 55905
Barnes-Jewish Hospital - Gastroenterology St Louis Missouri 63110
University of Nevada School of Medicine Las Vegas Nevada 89154
Dartmouth Hitchcock Medical Center - Cancer Center Lebanon New Hampshire 03756
Morristown Medical Center - Gastroenterology Morristown New Jersey 07960
Albany Medical Center Albany New York 12208
North Shore University Hospital - Gastroenterology Manhasset New York 11030
NYU Langone Medical Center New York New York 10016
Stony Brook University Medical Center New York New York 10016
Weill Medical College of Cornell University New York New York 10021
Icahn School of Medicine at Mount Sinai New York New York 10028
Columbia University Medical Center New York New York 10032
Lenox Hill Hospital New York New York 10075
Cleveland Clinic Cleveland Ohio 44106
OHSU Digestive Health Center Portland Oregon 97239
Harvard Medical School-Beth Israel Deaconess Medical Center Hershey Pennsylvania 17033
Penn State Hershey Medical Center - Surgery Hershey Pennsylvania 17033
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107
Allegheny General Hospital Pittsburgh Pennsylvania 15212
University Surgical Associates-Rhode Island Hospital Providence Rhode Island 02904
Medical University of South Carolina Charleston South Carolina 29425
Rapid City Medical Center Rapid City South Dakota 57701
Vanderbilt University Medical Center Nashville Tennessee 37232
UT Southwestern Medical Center - Gastroenterology - Gastroenterology Dallas Texas 75390
Baylor College of Medicine (BCM) - Gastroenterology Houston Texas 77030
University of Utah Salt Lake City Utah 84112
University of Virginia Charlottesville Virginia 22908
Carilion Clinic Roanoke Virginia 24016
Virginia Mason Medical Center - Gastroenterology Seattle Washington 98101
Swedish Medical Center Seattle Washington 98104
Aurora St. Luke's Medical Center Milwaukee Wisconsin 53215
Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 91 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03279081, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 18, 2024 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03279081 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →