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)
ADMIRE-CD-II
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
2 other identifiers
interventional
568
15 countries
159
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2017
Longer than P75 for phase_3
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedStudy Start
First participant enrolled
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2023
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
August 1, 2024
5.4 years
July 21, 2017
July 12, 2024
August 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Combined Remission at Week 24
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central magnetic resonance imaging (MRI) assessment. Percentages are rounded off to whole number at the nearest decimal.
Week 24
Secondary Outcomes (13)
Percentage of Participants With Clinical Remission at Week 24
Week 24
Time to Clinical Remission at Week 24
Week 24
Percentage of Participants With Combined Remission at Week 52
Week 52
Percentage of Participants With Clinical Remission at Week 52
Week 52
Percentage of Participants With Clinical Response at Week 24
Week 24
- +8 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo (saline) 24 milliliters (mL) was administered once by local injection.
Cx601
EXPERIMENTALCx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection.
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent.
- Participants of either gender greater than or equal to (\>=) 18 years and less than or equal to (\<=) 75 years of age.
- Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria.
- Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment; a central reading of a locally performed contrast enhanced (gadolinium) pelvic MRI will be performed to confirm location of the fistula and potential associated perianal abscess(es). Fistula(s) must have been draining for at least 6 weeks prior to Screening visit. Actively draining simple subcutaneous fistula(s), at the time of Screening visit, are not allowed in this study. A complex perianal fistula is defined as a fistula that meets one or more of the following criteria :
- High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric.
- Presence of \>=2 external openings.
- Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm at least 2 dimensions on MRI must be confirmed to have been drained adequately by the surgeon during the preparation curettage in order to be eligible.
- Clinically controlled, nonactive or mildly active CD, during the last six months prior to Screening visit with:
- A patient reported outcomes (PRO-2) score \<14 at Screening, AND
- A colonoscopy documenting the absence of ulcers larger than 0.5 cm in the colonic mucosa:
- \- If colonoscopy data are not available within 6 months prior to Screening:
- A simple endoscopic score for Crohn's Disease (SES-CD) \<=6 with absence of rectal ulcers larger than 0.5 cm must be documented in a colonoscopy performed at Screening before randomization.
- \- If colonoscopy data are available within 6 months prior to Screening, the following must be documented, otherwise a new colonoscopy (as above) will be mandatory:
- The absence of ulcers larger than 0.5 cm in the colonic mucosa AND
- the improvement or no worsening in abdominal pain and/or in the diarrhea, sustained for one week or more, since the last colonoscopy was performed in the clinical records until Screening visit.
- +13 more criteria
You may not qualify if:
- Concomitant rectovaginal or rectovesical fistula(s).
- Participant naïve to prior specific medical treatment for complex perianal fistula(s) including immunosuppressant (IS) or anti-TNFs.
- Presence of a perianal collection \>2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon during the preparation procedure (week -3 to day 0).
- Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large \>0.5 cm ulcers in the rectum) that make impossible to follow the surgery procedure manual.
- Participant with diverting stomas.
- Active, uncontrolled infection requiring parenteral antibiotics.
- Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit.
- Participants with major alteration on any of the following laboratory tests or increased risk for the surgical procedure:
- Serum creatinine levels \>1.5 times the ULN
- Total bilirubin \>1.5 ULN
- Aspartate Transaminase (AST)/ Alanine Transaminase (ALT) \>3 times ULN
- Hemoglobin \<10.0 g/dL
- Platelets \<75.0\*10\^9/L
- Albuminemia \<3.0 g/dL
- Suspected or documented infectious enterocolitis within two weeks prior to Screening visit.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tigenix S.A.U.lead
Study Sites (159)
Scottsdale Mayo Clinic
Scottsdale, Arizona, 85259, United States
UC San Diego Health Systems
La Jolla, California, 92037, United States
University of Southern California (USC) Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer
Orange, California, 92868, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Kaiser Permamente
San Francisco, California, 91115, United States
University of California San Francisco
San Francisco, California, 94115, United States
Vallejo Hospital and Medical Offices
Vallejo, California, 94589, United States
Cedar-Sinai Medical Center
West Hollywood, California, 90048, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Hartford Hospital - Gastroenterology
Farmington, Connecticut, 06032, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20017, United States
Mayo Clinic - Gastroenterology
Jacksonville, Florida, 32224, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Florida Hospital Orlando
Orlando, Florida, 32804, United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606, United States
Florida Hospital Tampa
Tampa, Florida, 33613, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago Medicine - Colon & Rectal Surgery
Chicago, Illinois, 60637, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Indiana University - Colon and Rectal
Indianapolis, Indiana, 46237, United States
University of Kansas Sxchool of Medicine
Kansas City, Kansas, 66160, United States
University of Louisville
Louisville, Kentucky, 40292, United States
Digestive Health Center of Louisiana
Baton Rouge, Louisiana, 70809, United States
Colon and Rectal Surgery Associates
Metairie, Louisiana, 70001, United States
University Medical Center - New Orleans
New Orleans, Louisiana, 71103, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins Medicine - The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachussetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 08807, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01803, United States
University of Massachusetts - colon & rectal surgery
Worcester, Massachusetts, 01605, United States
Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital - Gastroenterology
St Louis, Missouri, 63110, United States
University of Nevada School of Medicine
Las Vegas, Nevada, 89154, United States
Dartmouth Hitchcock Medical Center - Cancer Center
Lebanon, New Hampshire, 03756, United States
Morristown Medical Center - Gastroenterology
Morristown, New Jersey, 07960, United States
Albany Medical Center
Albany, New York, 12208, United States
North Shore University Hospital - Gastroenterology
Manhasset, New York, 11030, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Stony Brook University Medical Center
New York, New York, 10016, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10028, United States
Columbia University Medical Center
New York, New York, 10032, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Cleveland Clinic
Cleveland, Ohio, 44106, United States
OHSU Digestive Health Center
Portland, Oregon, 97239, United States
Harvard Medical School-Beth Israel Deaconess Medical Center
Hershey, Pennsylvania, 17033, United States
Penn State Hershey Medical Center - Surgery
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University Surgical Associates-Rhode Island Hospital
Providence, Rhode Island, 02904, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Rapid City Medical Center
Rapid City, South Dakota, 57701, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center - Gastroenterology - Gastroenterology
Dallas, Texas, 75390, United States
Baylor College of Medicine (BCM) - Gastroenterology
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Carilion Clinic
Roanoke, Virginia, 24016, United States
Virginia Mason Medical Center - Gastroenterology
Seattle, Washington, 98101, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology
Milwaukee, Wisconsin, 53226, United States
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000, Belgium
AZ Groeninge - Campus Kennedylaan - Gastro-enterology
Kortrijk, West-Vlaanderen, 8500, Belgium
AZ Delta vzw - Maag-darm-leverziekten
Roeselare, West-Vlaanderen, 8800, Belgium
GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology
Antwerp, 2018, Belgium
Imelda Ziekenhuis
Antwerp, 2820, Belgium
UZ Gent - Gastroenterology
Ghent, 9000, Belgium
CHU de Liege - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Clinique Saint-Joseph (CHC)
Liège, 4000, Belgium
CHU Dinant Godinne UCL Namur
Namur, 5530, Belgium
University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Mount Sinai Hospital - Toronto - Gastroenterology
Toronto, Ontario, M5G 1X5, Canada
Kensington Screening Clinic - Gastroenterology
Toronto, Ontario, M5T 3A9, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3J4, Canada
McGill University Health Centre - Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
NH Hospital a.s.
Hořovice, Beroun, 268 31, Czechia
FN Hradec Kralove
Hradec Králové, 500 05, Czechia
Bispebjerg Hospital
Copenhagen, Copenhague, 2400, Denmark
Aarhus University Hospital - Department of Hepatology and Gastroenterology, Lever-Mave- og Tarmsygdomme Klinik, krydspunkt C216
Aarhus, 8200, Denmark
Odense Universitetshospital
Odense, Denmark
CHU de Nice
Nice, Alpes-Maritimes, 06202, France
CHU de Clermont-Ferrand - Estaing
Clermont-Ferrand, Auvergne, 63003, France
Centre Hospitalier Universitaire De Toulouse - Hopital De Ra
Toulouse, Haute-Garonne, 31059, France
CHRU Hopital De Pontchaillou
Rennes, Ille-et-Vilaine, 35033, France
CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie
Vandœuvre-lès-Nancy, Lorraine, 54511, France
CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie
Lille, Nord, 59000, France
CHU Saint Etienne
Saint Priest En Jarez, Pays de la Loire Region, 42270, France
CHU Amiens-Picardie
Amiens, Picardie, 80054, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, 69495, France
Paris St. Joseph Hospital
Paris, 75014, France
Hopital Beaujon
Clichy, Île-de-France Region, 92110, France
Hopital Saint Louis - Gastro-hepatoenterologie
Paris, Île-de-France Region, 75010, France
Universitatsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Klinikum der Universitat Munchen - Campus Grosshadern
München, Bavaria, 81377, Germany
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, 69590, Germany
Universitatsklinikum Dresden
Dresden, Saxony, 01307, Germany
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
Szeged, Csongrád megye, 6720, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, H-4032, Hungary
MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly
Budapest, Pest County, 1062, Hungary
Semmelweis Egyetem
Budapest, Pest County, H-1088, Hungary
Rabin Med Ctr Beilinson Hosp
Petah Tikva, Central District, 4941492, Israel
Shaare Zedek Medical Center - Gastroenterology
Jerusalem, Jerusalem, 9103102, Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-
Jerusalem, Jerusalem, 91120, Israel
Rambam Medical Centre
Haifa, Northern District, 31096, Israel
Chaim sheba Medical Center
Tel Litwinsky, Tel Aviv, 5262000, Israel
Ospedale Santissima Annunziata
Cento, Ferrara, 44042, Italy
Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center
Rozzano, Milano, 20089, Italy
Policlinico S. Orsola Malpighi, AOU di Bologna-U.O. di Medicina Interna.
Bologna, 40138, Italy
AOU Policlinico di Modena - Gastroenterologia
Modena, 41124, Italy
II Universita degli Studi di Napoli
Napoli, 80131, Italy
Gastroenterology Section
Palermo, 90127, Italy
Universita degli studi di Pisa
Pisa, 56126, Italy
Policlinico Universitario Campus Biomedico - UOC di Gastroenterologia
Roma, 00128, Italy
A.O. San Camillo Forlanini
Roma, 00152, Italy
Complesso Integrato Columbus
Roma, 00168, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia
Udine, 33100, Italy
Azienda Ospedaliera Universitaria Integrata Verona (AOUI) -
Verona, 37134, Italy
Centrum Medyczne PROMED
Krakow, Lesser Poland Voivodeship, 31-411, Poland
Centrum Medyczne Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449, Poland
Wielospecjalistyczny Szpital Medicover
Warsaw, Masovian Voivodeship, 03-984, Poland
Endoskopia Sp z o.o.
Sopot, Pomeranian Voivodeship, 81-756, Poland
COPERNICUS Podmiot Leczniczy Sp. z o.o.
Gdansk, 80-803, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, 02-507, Poland
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
Lodz, Łódź Voivodeship, 90-647, Poland
University of Puerto Rico School of Medicine
San Juan, 00936, Puerto Rico
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
H.U. G.Trias i Pujol
Badalona, Barcelona, 08916, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 8208, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital de Sagunto
Sagunto, Valencia, 46520, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital del Mar
Barcelona, 8003, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
C.H.U. de Pontevedra
Pontevedra, 36071, Spain
H.U.V. del Rocio
Seville, 21005, Spain
Linkoping University Hospital - Department of Surgery
Linköping, Ostergotlands Lan [se-05], 581 85, Sweden
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI)
Glasgow, Glasgow City, G52 3NQ, United Kingdom
St. Mark's Hospital
Harrow, London, City of, HA1 3UJ, United Kingdom
Guys & St Thomas
London, London, City of, SE1 7EH, United Kingdom
Nottingham University Hospitals NHS Trust - Surgery
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
University Colleague London Hospital (UCLH)
London, NW1 2BU, United Kingdom
Wythenshawe Hospital - Gastroenterology
Manchester, M13 9WL, United Kingdom
Northern General Hospital
Sheffield, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2017
First Posted
September 12, 2017
Study Start
September 15, 2017
Primary Completion
January 23, 2023
Study Completion
July 26, 2023
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.