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)
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03279081
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 568 participants
Conditions and interventions
Conditions
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 15, 2017 (Actual)
- Primary completion
- Jan 23, 2023 (Actual)
- Completion
- Jul 26, 2023 (Actual)
- Last update posted
- Sep 19, 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 19, 2024 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03279081 live on ClinicalTrials.gov.