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)

August 22, 2024 updated by: Tigenix S.A.U.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
568

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2018
        • GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology
      • Antwerpen, Belgium, 2820
        • Imelda Ziekenhuis
      • Gent, Belgium, 9000
        • UZ Gent - Gastroenterology
      • Liege, Belgium, 4000
        • CHU de Liège - Domaine Universitaire du Sart Tilman
      • Liege, Belgium, 4000
        • Clinique Saint-Joseph (CHC)
      • Namur, Belgium, 5530
        • CHU Dinant Godinne UCL Namur
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • AZ Groeninge - Campus Kennedylaan - Gastro-enterology
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ Delta vzw - Maag-darm-leverziekten
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto - Gastroenterology
      • Toronto, Ontario, Canada, M5T 3A9
        • Kensington Screening Clinic - Gastroenterology
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre - Montreal General Hospital
      • Montreal, Quebec, Canada, H2X 3J4
        • Centre Hospitalier de l'Université de Montréal
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • FN Hradec Králové
    • Beroun
      • Horovice, Beroun, Czechia, 268 31
        • NH Hospital a.s.
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital - Department of Hepatology and Gastroenterology, Lever-Mave- og Tarmsygdomme Klinik, krydspunkt C216
      • Odense, Denmark
        • Odense Universitetshospital
    • Copenhague
      • Kobenhavn, Copenhague, Denmark, 2400
        • Bispebjerg Hospital
  • France
      • Paris, France, 75014
        • Paris St. Joseph Hospital
    • Alpes-Maritimes
      • Nice Cedex 03, Alpes-Maritimes, France, 06202
        • CHU de Nice
    • Auvergne
      • Clermont-Ferrand cedex 1, Auvergne, France, 63003
        • CHU de Clermont-Ferrand - Estaing
    • Haute-Garonne
      • Toulouse cedex 09, Haute-Garonne, France, 31059
        • Centre Hospitalier Universitaire De Toulouse - Hopital De Ra
    • Ile-de-France
      • Clichy, Ile-de-France, France, 92110
        • Hôpital Beaujon
      • Paris, Ile-de-France, France, 75010
        • Hopital Saint Louis - Gastro-hepatoenterologie
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • CHRU Hopital de Pontchaillou
    • Loire
      • St Priest en Jarez, Loire, France, 42270
        • CHU Saint Etienne
    • Lorraine
      • Vandoeuvre-les-Nancy, Lorraine, France, 54511
        • CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie
    • Nord
      • Lille, Nord, France, 59000
        • CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie
    • Picardie
      • AMIENS cedex 1, Picardie, France, 80054
        • CHU AMIENS-PICARDIE
    • Rhone
      • Pierre-Benite, Rhone, France, 69495
        • Centre Hospitalier Lyon Sud
  • Germany
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitätsklinikum Erlangen
      • Munchen, Bayern, Germany, 81377
        • Klinikum der Universität München - Campus Grosshadern
    • Hessen
      • Frankfurt/Main, Hessen, Germany, 69590
        • Klinikum der Johann Wolfgang Goethe-Universität
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitätsklinikum Dresden
  • Hungary
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, H-4032
        • Debreceni Egyetem Klinikai Kozpont
    • Pest
      • Budapest, Pest, Hungary, 1062
        • MH Egészségügyi Központ - Gasztroenterológiai Osztály
      • Budapest, Pest, Hungary, H-1088
        • Semmelweis Egyetem
  • Israel
    • HaMerkaz
      • Petah Tikva, HaMerkaz, Israel, 4941492
        • Rabin Med Ctr Beilinson Hosp
    • HaZafon
      • Haifa, HaZafon, Israel, 31096
        • Rambam Medical Centre
    • Tel-Aviv
      • Tel Hashomer, Tel-Aviv, Israel, 5262000
        • Chaim Sheba Medical Center
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 9103102
        • Shaare Zedek Medical Center - Gastroenterology
      • Jerusalem, Yerushalayim, Israel, 91120
        • Hadassah Medical Organization, Hadassah Medical Center, Ein-
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S. Orsola Malpighi, AOU di Bologna-U.O. di Medicina Interna.
      • Modena, Italy, 41124
        • AOU Policlinico di Modena - Gastroenterologia
      • Napoli, Italy, 80131
        • II Universita degli Studi di Napoli
      • Palermo, Italy, 90127
        • Gastroenterology Section
      • Pisa, Italy, 56126
        • Università degli studi di Pisa
      • Roma, Italy, 00168
        • Complesso Integrato Columbus
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00152
        • A.O. San Camillo Forlanini
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Biomedico - UOC di Gastroenterologia
      • Udine, Italy, 33100
        • Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona (AOUI) -
    • Ferrara
      • Cento, Ferrara, Italy, 44042
        • Ospedale Santissima Annunziata
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center
  • Poland
      • Gdansk, Poland, 80-803
        • COPERNICUS Podmiot Leczniczy Sp. z o.o.
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-449
        • Centrum Medyczne Melita Medical
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-647
        • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-411
        • Centrum Medyczne Promed
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 03-984
        • Wielospecjalistyczny Szpital Medicover
    • Pomorskie
      • Sopot, Pomorskie, Poland, 81-756
        • Endoskopia Sp z o.o.
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico School of Medicine
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 8003
        • Hospital del Mar
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Pontevedra, Spain, 36071
        • C.H.U. de Pontevedra
      • Sevilla, Spain, 21005
        • H.U.V. del Rocio
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07120
        • Hospital Universitario Son Espases
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • H.U. G.Trias i Pujol
      • Sabadell, Barcelona, Spain, 8208
        • Corporacio Sanitaria Parc Tauli
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Hospital de Sagunto
  • Sweden
    • Ostergotlands Lan [se-05]
      • Linkoping, Ostergotlands Lan [se-05], Sweden, 581 85
        • Linkoping University Hospital - Department of Surgery
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University Colleague London Hospital (UCLH)
      • Manchester, United Kingdom, M13 9WL
        • Wythenshawe Hospital - Gastroenterology
      • Sheffield, United Kingdom, S10 2JF
        • Northern General Hospital
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G52 3NQ
        • NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI)
    • London, City Of
      • Harrow, London, City Of, United Kingdom, HA1 3UJ
        • St. Mark's Hospital
      • London, London, City Of, United Kingdom, SE1 7EH
        • Guys & St Thomas
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust - Surgery
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Scottsdale Mayo Clinic
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego Health Systems
      • Los Angeles, California, United States, 90033
        • University of Southern California (USC) Norris Comprehensive Cancer Center
      • Orange, California, United States, 92868
        • UC Irvine Medical Center - Chao Family Comprehensive Cancer
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
      • San Francisco, California, United States, 94115
        • University of California San Francisco
      • San Francisco, California, United States, 91115
        • Kaiser Permamente
      • Vallejo, California, United States, 94589
        • Vallejo Hospital and Medical Offices
      • West Hollywood, California, United States, 90048
        • Cedar-Sinai Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Hartford Hospital - Gastroenterology
      • New Haven, Connecticut, United States, 06519
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
        • MedStar Georgetown University Hospital
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Gastroenterology
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Orlando, Florida, United States, 32804
        • Florida Hospital Orlando
      • Tampa, Florida, United States, 33613
        • Florida Hospital Tampa
      • Tampa, Florida, United States, 33606
        • USF Health South Tampa Center for Advanced Healthcare
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine - Colon & Rectal Surgery
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana University - Colon and Rectal
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Sxchool of Medicine
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Digestive Health Center of Louisiana
      • Metairie, Louisiana, United States, 70001
        • Colon and Rectal Surgery Associates
      • New Orleans, Louisiana, United States, 71103
        • University Medical Center - New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medicine - The Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachussetts General Hospital
      • Boston, Massachusetts, United States, 08807
        • Boston Medical Center
      • Burlington, Massachusetts, United States, 01803
        • Lahey Hospital & Medical Center
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts - colon & rectal surgery
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital - Gastroenterology
    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • University of Nevada School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center - Cancer Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center - Gastroenterology
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital - Gastroenterology
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10028
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • Stony Brook University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Digestive Health Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center - Surgery
      • Hershey, Pennsylvania, United States, 17033
        • Harvard Medical School-Beth Israel Deaconess Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • University Surgical Associates-Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center - Gastroenterology - Gastroenterology
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine (BCM) - Gastroenterology
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center - Gastroenterology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent.
  2. Participants of either gender greater than or equal to (>=) 18 years and less than or equal to (<=) 75 years of age.
  3. Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria.

  4. 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.

  5. 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.

    AND

    o No hemoglobin decrease >=2.0 gram per deciliter (g/dL) or an unexplained rising C-reactive protein (CRP), > 5.0 milligram per liter (mg/L) to a concentration above the referenced upper limit of normal (ULN) (unless the rise is due to a known process other than luminal Crohn's Disease), since the last colonoscopy was performed as compared to results during the Screening visit.

    AND

    o no initiation or intensification of treatment with corticosteroids, immunosuppressants or monoclonal antibodies (mAbs) dose regimen since the last endoscopy up to Screening visit.

  6. Participants whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response while they were receiving either an immunosuppressive agent or tumour necrosis factor (TNF)-alpha antagonist or vedolizumab or ustekinumab, or having documented intolerance to any of these treatments administered at least at approved or recommended doses during the minimum period mentioned:

    • Immunosuppressive agents: at least 3 months treatment with azathioprine (2-3 milligram per kilogram per day [mg/kg/day]), 6-mercaptopurine (1-1.5 mg/kg/day), or subcutaneous/intramuscular methotrexate (25 mg/week) prior to Screening for the study.
    • TNFalpha antagonists:
    • Infliximab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: 1 intravenous dose of 5 milligram per kilogram (mg/kg) followed by the same dose 2 and 6 weeks after. For maintenance: 5-10 mg/kg intravenously every 8 weeks, or more frequently.
    • Adalimumab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn's disease prior to screening for the study. For induction: 1 subcutaneous dose of 160 milligram (mg), followed by 80 mg 2 weeks after. For maintenance: 40 mg subcutaneously every other week, or weekly.
    • Certolizumab l: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: 1 subcutaneous dose of 400 mg, followed by the same dose 2 and 4 weeks after. For maintenance: 400 mg subcutaneously every 2 to 4 weeks.
    • Anti-integrin: at least 14 weeks treatment of the approved dose for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: Vedolizumab 300 mg. For maintenance: Vedolizumab 300 mg every 4 to 8 weeks.
    • Anti-interleukin (IL)-12/23: at least 16 weeks treatment of the approved dose in Crohn´s disease prior to screening for the study. For induction: Ustekinumab, approximately 6mg/kg intravenously initially then followed by 90 mg subcutaneously every 8 weeks.
  7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 international units [IU] human chorionic gonadotropin [hCG]). Both WCBP or male participants participating in this study, with a WCBP as partner, must agree to use an adequate method of contraception during the entire duration of the study. An adequate method of contraception is defined as complete, non-periodic sexual abstinence (refraining from heterosexual intercourse), single-barrier method, vasectomy, adequate hormonal contraception (to have started at least 7 days prior to Screening visit), or an intra-uterine device (to have been in place for at least 2 months prior to Screening visit).

Exclusion Criteria:

  1. Concomitant rectovaginal or rectovesical fistula(s).
  2. Participant naïve to prior specific medical treatment for complex perianal fistula(s) including immunosuppressant (IS) or anti-TNFs.
  3. 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).
  4. 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.
  5. Participant with diverting stomas.
  6. Active, uncontrolled infection requiring parenteral antibiotics.
  7. Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit.

  8. 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
  9. Suspected or documented infectious enterocolitis within two weeks prior to Screening visit.
  10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit. Participants with basal-cell carcinoma of the skin completely resected outside the perineal region can be included.
  11. Current or recent (within 6 months prior to the Screening visit) history of severe, progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (GI) (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that may result in participants increased risk from study participation and/or lack of compliance with study procedures.
  12. Participants with primary sclerosing cholangitis.
  13. Participants with known chronically active hepatopathy of any origin, including cirrhosis and participants with persistent positive Hepatitis B Virus (HBV) surface antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive serology for Hepatitis C Virus (HCV) and quantitative HCV PCR within 6 months prior to Screening.
  14. Congenital or acquired immunodeficiencies, including participants known to be HIV carriers
  15. Known allergies or hypersensitivity to penicillin or aminoglycosides; Dulbecco Modified Eagle's Medium (DMEM); bovine serum; local anaesthetics or gadolinium (MRI contrast).
  16. Contraindication to MRI scan (example, due to the presence of pacemakers, hip replacements or severe claustrophobia).
  17. Severe trauma within 6 months prior to Screening visit.
  18. Pregnant or breastfeeding women.
  19. Participants who do not wish to or cannot comply with study procedures.
  20. Participants currently receiving, or having received any investigational drug within 3 months prior to Screening visit.
  21. Participants previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study.
  22. Any major surgery of the GI tract (including one or more segments of the colon or terminal ileum) within 6 months prior the screening or any minor surgery of the GI tract within 3 months prior to screening.
  23. Participants who had local perianal surgery other than drainage for the fistula within 6 months prior to the Screening visit, or those who may need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study.
  24. Contraindication to the anaesthetic procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo (saline) 24 milliliters (mL) was administered once by local injection.
Other: Placebo
Cx601 placebo-matching eASCs intralesional injection.
Experimental: Cx601
Cx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection.
Drug: Cx601
Cx601 eASCs intralesional injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Combined Remission at Week 24
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Remission at Week 24
Time Frame: Week 24
Clinical remission was defined as closure of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.
Week 24
Time to Clinical Remission at Week 24
Time Frame: Week 24
Time to clinical remission was defined as the time from treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.
Week 24
Percentage of Participants With Combined Remission at Week 52
Time Frame: Week 52
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections >2 cm (in at least 2 dimensions) confirmed by blinded central MRI assessment. Percentages are rounded off to whole number at the nearest decimal.
Week 52
Percentage of Participants With Clinical Remission at Week 52
Time Frame: Week 52
Clinical remission was defined as closure of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.
Week 52
Percentage of Participants With Clinical Response at Week 24
Time Frame: Week 24
Clinical response was defined as closure of at least 50 percent (%) of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.
Week 24
Percentage of Participants With Clinical Response at Week 52
Time Frame: Week 52
Clinical response was defined as closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.
Week 52
Time to Clinical Remission at Week 52
Time Frame: Week 52
Time to clinical remission was defined as the time from treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.
Week 52
Time to Clinical Response at Week 24
Time Frame: Week 24
Time to clinical response was defined as the time from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression, as clinically assessed.
Week 24
Time to Clinical Response at Week 52
Time Frame: Week 52
Time to clinical response was defined as time from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.
Week 52
Percentage of Participants With Relapse by Week 52 After Achieving Combined Remission at Week 24
Time Frame: From Week 24 to Week 52
Relapse was defined as reopening of any of the treated fistulas external openings with active drainage as clinically assessed, or the development of a perianal fluid collection >2 cm of the treated perianal fistula confirmed by centrally read MRI assessment in participants who were in combined remission at week 24. Percentages are rounded off to whole number at the nearest decimal.
From Week 24 to Week 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
Time Frame: From first dose of study drug to end of follow up period (up to Week 52)
An adverse event(AE)=any untoward medical occurrence in a clinical investigation participant receiving a medicinal product; it did not necessarily have to have a causal relationship with this treatment. Serious adverse event(SAE)=any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital abnormality/birth defect, or was a medically significant event or required intervention to prevent at least one of the outcomes listed above, or was a suspected transmission of an infectious agent. AESIs included tumorigenicity, ectopic tissue formation, hypersensitivity reactions, transmission of infectious agents, immunogenicity/alloimmune reactions, and medication errors, as reported by the investigator. TEAE=AE whose onset occurred, severity worsened, or intensity increased after receiving the study treatment.
From first dose of study drug to end of follow up period (up to Week 52)
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Time Frame: From first dose of study drug to end of follow up period (up to Week 52)
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinically significant vital signs assessment was based on investigator interpretation. Number of participants with clinically significant changes in vital signs were reported.
From first dose of study drug to end of follow up period (up to Week 52)
Number of Participants With Clinically Significant Changes in Laboratory Parameters
Time Frame: From first dose of study drug to end of follow up period (up to Week 52)
Laboratory parameters included blood chemistry and hematology. Clinically significant laboratory parameters assessment was based on investigator interpretation. Number of participants with clinically significant changes in laboratory parameters (hematology and blood chemistry) were reported.
From first dose of study drug to end of follow up period (up to Week 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tigenix S.A.U.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cx601-0303
  • 2017-000725-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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