Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
NCT ID: NCT04075825
Last Updated: 2025-04-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2019-11-05
2024-04-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula
NCT04118088
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease
NCT04701411
A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer
NCT04971525
Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease
NCT03706456
Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
NCT04010526
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will enroll approximately 150 patients. Participants who received darvadstrocel or placebo in study ADMIRE-CD II (Cx601-0303, NCT03279081) and who have completed the 52 weeks of the study will be enrolled in this long-term extension study.
This multi-center study will be conducted worldwide. The overall time to participate in this study is 104 weeks (in addition to the 52 weeks on ADMIRE-CD II study). Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment. After unblinding of the ADMIRE-CD II study, the LTE study will be conducted as an open-label study. Participants will remain in the treatment group assigned in the ADMIRE-CD II study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants who received darvadstrocel placebo-matching expanded adipose-derived stem cells (eASCs) intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Placebo
Darvadstrocel placebo-matching eASCs intralesional injection received in previous ADMIRE-CD II study. No drug administration in this study.
Darvadstrocel
Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Darvadstrocel
Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection darvadstrocel received in previous ADMIRE-CD II study. No drug administration in this study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Darvadstrocel placebo-matching eASCs intralesional injection received in previous ADMIRE-CD II study. No drug administration in this study.
Darvadstrocel
Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection darvadstrocel received in previous ADMIRE-CD II study. No drug administration in this study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Francisco
San Francisco, California, United States
Cedar-Sinai Medical Center
West Hollywood, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Cleveland Clinic Florida
Fort Lauderdale, Florida, United States
University of Miami Hospital
Miami, Florida, United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
Indiana University - Colon and Rectal
Indianapolis, Indiana, United States
University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic
Kansas City, Kansas, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Massachussetts General Hospital - Gastroenterology
Boston, Massachusetts, United States
Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery
Rochester, Minnesota, United States
Dartmouth Hitchcock Medical Center - Cancer Center
Lebanon, New Hampshire, United States
Morristown Medical Center - Gastroenterology
Morristown, New Jersey, United States
Northwell Health
Manhasset, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Penn State Hershey Medical Center - Surgery
Hershey, Pennsylvania, United States
Brown Surgical Associates,Inc.
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Mason Medical Center - Gastroenterology
Seattle, Washington, United States
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
GZA Sint-Vincentius
Antwerp, , Belgium
NH Hospital a.s.
Hořovice, , Czechia
FN Hradec Kralove
Hradec Králové, , Czechia
CHRU de Brabois Hopitaux de Brabois
Vandœuvre-lès-Nancy, Nancy, France
CHRU de Lille - Hopital Claude Huriez - Gastroenterologie
Lille, Nord, France
CHU de Clermont-Ferrand - Estaing
Clermont-Ferrand, , France
Hopital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti
Rennes, , France
Paris St. Joseph Hospital
Paris, Île-de-France Region, France
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Szeged, Csongrád megye, Hungary
MH Egeszsegugyi Kozpont
Budapest, Pest County, Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Gyermekgyogyaszati Klinika
Debrecen, , Hungary
Rabin Medical Center, Beilinson Hospital -Gastroenterology
Petah Tikva, Central District, Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-
Jerusalem, Jerusalem, Israel
Rambam Medical Centre
Haifa, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
AOU Policlinico di Modena - Gastroenterologia
Modena, , Italy
Complesso Integrato Columbus, Universita Cattolica del Sacro Cuore
Roma, , Italy
PU A. Gemelli, Universita Cattolica del Sacro Cuore
Roma, , Italy
Centrum Medyczne Melita Medical
Wroclaw, Lower Silesian Voivodeship, Poland
Wielospecjalistyczny Szpital Medicover
Warsaw, , Poland
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
H.U. G.Trias i Pujol
Badalona, Barcelona, Spain
Parc Tauli Hospital Universitari
Sabadell, Barcelona, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Clinic De Barcelona
Barcelona, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
C.H.U. de Pontevedra
Pontevedra, , Spain
H.U.V. del Rocio
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain more information about this study, click this link.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-000333-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Darvadstrocel-3003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.