Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease

Study Purpose

The purpose of this 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. ADMIRE-CD II study

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed informed consent 2. Patients of either gender ≥ 18 years and ≤75 years of age 3. Patients with Crohn's Disease (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 5. Clinically controlled, non active or mildly active CD, during the last six months prior to Screening visit. 6. Patients 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 TNF-α antagonist or vedolizumab or ustekinumab, or having documented intolerance 7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both WCBP or male patients 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.

Exclusion Criteria:

1. Concomitant rectovaginal or rectovesical fistula(s) 2. Patient naïve to prior specific medical treatment for complex perianal fistula(s) including 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 4. Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large [> 0.5 cm diameter] ulcers in the rectum) that make impossible to follow the surgery procedure manual 5. Patient with diverting stomas 6. Active, uncontrolled infection requiring parenteral antibiotics 7. Patient with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit 8. Patients with major alteration on any of the following laboratory tests or increased risk for the surgical procedure: 1. Serum creatinine levels >1.5 times the ULN 2. Total bilirubin >1.5 ULN 3. AST/ALT >3 times ULN 4. Hemoglobin <10.0 g/dL 5. Platelets <75.0 x109/L 6. 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. Patients 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 (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that may result in patients increased risk from study participation and/or lack of compliance with study procedures 12. Patients with primary sclerosing cholangitis 13. Patients with known chronically active hepatopathy of any origin, including cirrhosis and patients with persistent positive HBV surface antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive serology for HCV and quantitative HCV PCR within 6 months prior to Screening. 14. Congenital or acquired immunodeficiencies, including patients known to be HIV carriers 15. Known allergies or hypersensitivity to penicillin or aminoglycosides; DMEM (Dulbecco Modified Eagle's Medium); bovin serum; local anaesthetics or gadolinium (MRI contrast) 16. Contraindication to MRI scan (e.g., 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. Patients who do not wish to or cannot comply with study procedures 20. Patients currently receiving, or having received any investigational drug within 3 months prior to Screening visit 21. Patients 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. Patients 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03279081

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
TiGenix S.A.U.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Belgium, Czechia, France, Hungary, Israel, Italy, Poland, Spain

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn's Disease
Additional Details

The current multicentre phase III study is proposed to evaluate the efficacy and safety of Cx601 compared to placebo for the treatment of complex perianal fistula(s) in patients with Crohn's disease at Week 24 with a follow-up period up to 52 weeks. The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both patient and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy . The study will follow an add-on design, patients receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the Crohn's disease (CD) will be allowed to continue it throughout the study. Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital de Sagunto, Valencia, Spain

Status

Active, not recruiting

Address

Hospital de Sagunto

Valencia, ,

Hospital Universitario Virgen Del Rocío, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Del Rocío

Sevilla, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Pontevedra, Spain

Status

Recruiting

Address

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Hospital Universitario Son Espases, Palma De Mallorca, Spain

Status

Recruiting

Address

Hospital Universitario Son Espases

Palma De Mallorca, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundación Jiménez Díaz

Madrid, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Hospital Universitario de la Paz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de la Paz

Madrid, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Hospital Universitario de Fuenlabrada, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de Fuenlabrada

Madrid, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, ,

Hospital Ramón y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Ramón y Cajal

Madrid, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Hospital Clínico San Carlos, Madrid, Spain

Status

Active, not recruiting

Address

Hospital Clínico San Carlos

Madrid, ,

Hospital del Mar, Barcelona, Spain

Status

Recruiting

Address

Hospital del Mar

Barcelona, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Corporacio Sanitaria Parc Taulil, Barcelona, Spain

Status

Recruiting

Address

Corporacio Sanitaria Parc Taulil

Barcelona, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Barcelona, Spain

Status

Recruiting

Address

Hospital Clínic i Provincial de Barcelona

Barcelona, , 08036

Site Contact

Sponsor

info@tigenix.com

+34918049264

Centrum Medyczne Melita Medical, Wrocław, Poland

Status

Recruiting

Address

Centrum Medyczne Melita Medical

Wrocław, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Centrum Medyczne PROMED, Wołomin, Poland

Status

Recruiting

Address

Centrum Medyczne PROMED

Wołomin, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Warszawa, Poland

Status

Recruiting

Address

Wielospecjalistyczny Szpital Medicover Oddzial Chirurgiczny Ogolny

Warszawa, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Endoskopia Sp z o.o., Sopot, Poland

Status

Recruiting

Address

Endoskopia Sp z o.o.

Sopot, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Poznań, Poland

Status

Not yet recruiting

Address

Szpital Kliniczny im. Heliodora Swiecickiego UM im. K. Marcinkowskiego w Poznaniu

Poznań, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Verona, Italy

Status

Active, not recruiting

Address

Universita' degli studi di Verona-Dip.Scienze Chirurgiche

Verona, ,

Udine, Italy

Status

Active, not recruiting

Address

Hospital Universitario Santa Maria della Misericordia

Udine, ,

Ospedale Santissima Annunziata, Taranto, Italy

Status

Not yet recruiting

Address

Ospedale Santissima Annunziata

Taranto, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Humanitas Research Hospital, Rozzano, Italy

Status

Active, not recruiting

Address

Humanitas Research Hospital

Rozzano, ,

Roma, Italy

Status

Recruiting

Address

Policlinico Universitario Agostino Gemelli

Roma, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Roma, Italy

Status

Active, not recruiting

Address

Hospital Universitario Policlínico Universitario Campus Bio-Medico

Roma, ,

Roma, Italy

Status

Active, not recruiting

Address

Azienda Ospedaliera San Camillo Forlanini

Roma, ,

Universita degli studi di Pisa, Pisa, Italy

Status

Not yet recruiting

Address

Universita degli studi di Pisa

Pisa, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Palermo, Italy

Status

Active, not recruiting

Address

Azienda Ospedaliera Universitaria-Policlinico Paolo Giaccone

Palermo, ,

Napoli, Italy

Status

Not yet recruiting

Address

Università degli Studi di Napoli Federico II

Napoli, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Modena, Italy

Status

Active, not recruiting

Address

Policlinico of Modena University Hospital of Modena

Modena, ,

Università Cattolica del Sacro Cuore, Milano, Italy

Status

Not yet recruiting

Address

Università Cattolica del Sacro Cuore

Milano, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

L'Aquila, Italy

Status

Not yet recruiting

Address

Università degli Studi dell'Aquila-Facolta di Medicina

L'Aquila, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Policlinico S.Orsola-Malpighi, Bologna, Italy

Status

Not yet recruiting

Address

Policlinico S.Orsola-Malpighi

Bologna, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Chaim Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Chaim Sheba Medical Center

Ramat Gan, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Rabin Medical Center-Beilinson Hospital, Petah tikva, Israel

Status

Active, not recruiting

Address

Rabin Medical Center-Beilinson Hospital

Petah tikva, ,

Shaare Zedek Medical Center, Jerusalem, Israel

Status

Not yet recruiting

Address

Shaare Zedek Medical Center

Jerusalem, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Jerusalem, Israel

Status

Not yet recruiting

Address

Hadassah Medical Center - Hadassah University Hospital Ein Kerem

Jerusalem, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Rambam Medical Centre, Haifa, Israel

Status

Not yet recruiting

Address

Rambam Medical Centre

Haifa, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Szeged, Hungary

Status

Recruiting

Address

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Pécs, Hungary

Status

Active, not recruiting

Address

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

Pécs, ,

Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary

Status

Active, not recruiting

Address

Debreceni Egyetem Klinikai Kozpont

Debrecen, ,

Semmelweis Egyetem, Budapest, Hungary

Status

Recruiting

Address

Semmelweis Egyetem

Budapest, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

MH Egeszsegugyi Kozpont, Budapest, Hungary

Status

Active, not recruiting

Address

MH Egeszsegugyi Kozpont

Budapest, ,

Vandœuvre-lès-Nancy, France

Status

Recruiting

Address

Centre Hospitalier Régional Universitaire de Nancy, Hospital Brabois Adulte

Vandœuvre-lès-Nancy, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Toulouse, France

Status

Not yet recruiting

Address

Centre Hospitalier Universitaire De Toulouse

Toulouse, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

CHU Amiens Picardie site SUD, Salouël, France

Status

Not yet recruiting

Address

CHU Amiens Picardie site SUD

Salouël, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Saint-Priest-en-Jarez, France

Status

Not yet recruiting

Address

Centre Hospitalier Universitaire CHU de Saint-Étienne

Saint-Priest-en-Jarez, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

L'Hôpital Pontchaillou, Rennes, France

Status

Active, not recruiting

Address

L'Hôpital Pontchaillou

Rennes, ,

Pierre-Bénite, France

Status

Recruiting

Address

Centre hospitalier Lyon-Sud, Service d'hépato-gastroentérologie

Pierre-Bénite, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Hôpital Saint Louis - APHP, Paris, France

Status

Active, not recruiting

Address

Hôpital Saint Louis - APHP

Paris, ,

Centre Hospitalier Universitaire de Nice, Nice, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nice

Nice, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Hôpital Claude Huriez - CHRU Lille, Lille, France

Status

Recruiting

Address

Hôpital Claude Huriez - CHRU Lille

Lille, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Clichy, France

Status

Recruiting

Address

Hopital Beaujon Serv. de Gastro-entérologie et assistance nutritive

Clichy, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Clermont-Ferrand, France

Status

Active, not recruiting

Address

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, ,

NH Hospital Czech Republic, Prague, Czechia

Status

Recruiting

Address

NH Hospital Czech Republic

Prague, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Fakultní Nemocnice Hradec Králové, Nový Hradec Králové, Czechia

Status

Recruiting

Address

Fakultní Nemocnice Hradec Králové

Nový Hradec Králové, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

AZ Delta Roeselare‐Menen Wilgenstraat, Menen, Belgium

Status

Active, not recruiting

Address

AZ Delta Roeselare‐Menen Wilgenstraat

Menen, ,

Liège, Belgium

Status

Recruiting

Address

Centre Hospitalier Chretien (CHC) Clinique Saint‐ Joseph

Liège, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

UZ Leuven ‐ Campus Gasthuisberg, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven ‐ Campus Gasthuisberg

Leuven, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

Ghent University Hospital, Gent, Belgium

Status

Recruiting

Address

Ghent University Hospital

Gent, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

GZA St. Vincentiusziekenhuis, Antwerpen, Belgium

Status

Recruiting

Address

GZA St. Vincentiusziekenhuis

Antwerpen, ,

Site Contact

Sponsor

info@tigenix.com

+34918049264

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