96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,400 薬物数 : 1,417 - (DrugBank : 267) / 標的遺伝子数 : 168 - 標的パスウェイ数 : 214

  
56 trials found
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PhaseCountries
1NCT05262829
(ClinicalTrials.gov)
February 28, 20228/2/2022Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate and Severe Crohn's DiseaseA Single-arm, Open-label Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Moderate to Severe Crohn's DiseaseCrohn DiseaseBiological: Human Umbilical Cord Mesenchymal Stem CellsShanghai East HospitalNULLNot yet recruiting18 Years70 YearsAll40N/AChina
2NCT05039411
(ClinicalTrials.gov)
January 1, 20221/9/2021Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's DiseaseA Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's DiseasePerianal Fistula Due to Crohn's Disease;Fistula in AnoBiological: Human umbilical cord mesenchymal stem cells (UC-MSCs)CryoCord Sdn BhdUniversity of MalayaNot yet recruiting18 YearsN/AAll7Phase 1Malaysia
3NCT05075811
(ClinicalTrials.gov)
January 1, 202228/9/2021Study of Ossium Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in the Setting of Crohn's DiseaseA Phase IB/IIA Study of Ossium Vertebral Bone Marrow Derived Mesenchymal Stem Cells (vBM-MSC) for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the PouchPouch, Ileal;FistulaDrug: Ossium vBM-MSC;Other: PlaceboAmy LightnerOssium Health, Inc.Not yet recruiting18 Years75 YearsAll20Phase 1/Phase 2United States
4NCT04073472
(ClinicalTrials.gov)
June 1, 202123/8/2019Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn'sA Phase I Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the PouchCrohn's Disease;Fistula;Anal Fistula;Pouch, Ileal;Pouches, IleoanalDrug: mesenchymal stem cells (MSCs)The Cleveland ClinicNULLWithdrawn18 Years75 YearsAll0Phase 1United States
5EUCTR2017-000725-12-DK
(EUCTR)
07/04/202114/10/2020A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden
6NCT04791878
(ClinicalTrials.gov)
April 1, 20216/3/2021Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's DiseaseA Phase I Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's DiseasePerianal Fistula Due to Crohn's Disease (Disorder)Drug: Mesenchymal stem cellsAmy LightnerNULLRecruiting13 Years17 YearsAll10Phase 1United States
7EUCTR2017-000725-12-SE
(EUCTR)
30/03/202120/08/2020A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden
8EUCTR2020-003193-48-NL
(EUCTR)
25/01/202121/11/2020A Phase 3 Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease.A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel inthe Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease over aPeriod of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks. - Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Crohn’s Disease. Complex Perianal Fistulas in Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Darvadstrocel
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3Spain;Poland;Israel;Netherlands;Italy;Japan
9NCT04519671
(ClinicalTrials.gov)
November 19, 202017/8/2020Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's DiseaseA Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's DiseasePerianal Crohn Disease;Perianal Fistula;Crohn DiseaseDrug: Mesenchymal Stem Cells;Other: PlaceboAmy LightnerNULLRecruiting18 Years75 YearsAll40Phase 1/Phase 2United States
10NCT04939337
(ClinicalTrials.gov)
November 12, 202010/6/2021A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells(TH-SC01), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.Crohn's DiseaseDrug: TH-SC01Jinling Hospital, ChinaJiangsu Topcel-KH Pharmaceutical Co., LtdEnrolling by invitation18 Years70 YearsAll24Phase 1China
11EUCTR2019-000333-39-FR
(EUCTR)
07/11/202004/10/2019Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
12NCT04519697
(ClinicalTrials.gov)
October 28, 202017/8/2020Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's DiseaseA Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.Rectovaginal Fistula;Crohn Disease;Crohn Disease of Vulva;Rectolabial; FistulaDrug: Mesenchymal Stem Cells;Other: PlaceboAmy LightnerNULLRecruiting18 Years75 YearsFemale40Phase 1/Phase 2United States
13NCT04519684
(ClinicalTrials.gov)
October 28, 202017/8/2020Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's DiseaseA Phase IB/IIA Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the PouchIleal Pouch;Crohn DiseaseDrug: Mesenchymal stem cells;Other: PlaceboAmy LightnerNULLRecruiting18 Years75 YearsAll40Phase 1/Phase 2United States
14EUCTR2017-002491-10-AT
(EUCTR)
19/08/202011/05/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czechia;Czech Republic;Spain;Austria;Israel;Germany
15EUCTR2017-002491-10-FR
(EUCTR)
17/07/202009/03/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czech Republic;Spain;Austria;Germany;United Kingdom
16EUCTR2017-002491-10-DE
(EUCTR)
22/06/202009/03/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czechia;Czech Republic;Spain;Austria;Israel;Germany
17EUCTR2017-002491-10-ES
(EUCTR)
03/06/202006/03/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czech Republic;Spain;Austria;Germany;United Kingdom
18EUCTR2019-000333-39-BE
(EUCTR)
04/05/202021/01/2020Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Takeda Development Center Americas, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany
19EUCTR2017-002491-10-CZ
(EUCTR)
10/03/202027/11/2019Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom
20EUCTR2019-000333-39-IT
(EUCTR)
09/12/201924/05/2021Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: [Cx601]
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose
MILLENNIUM PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany
21NCT02677350
(ClinicalTrials.gov)
December 1, 20191/2/2016AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE)A Phase I, Pilot Trial to Evaluate the Safety and Efficacy of Injection of Allogeneic Mesenchymal Bone-Marrow Derived Human Stem Cells in Patients With Fistulizing Crohn's Disease.Crohn's Disease;Fistulizing Crohn's Disease;Stem CellsDrug: Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs)Joshua M HareNULLWithdrawn18 YearsN/AAll0Phase 1United States
22EUCTR2019-000333-39-CZ
(EUCTR)
15/10/201903/09/2019Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
23EUCTR2017-000725-12-DE
(EUCTR)
17/07/201928/02/2019A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
24EUCTR2017-000725-12-GB
(EUCTR)
17/04/201922/10/2018A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom
25NCT03901235
(ClinicalTrials.gov)
January 15, 20184/3/2019MSC Intratissular Injection in Crohn Disease PatientsTreatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem CellsEfficacy and SafetyBiological: Mesenchymal Stromal CellsUniversity of LiegeCentre Hospitalier Universitaire de LiegeRecruiting18 YearsN/AAll60Phase 1/Phase 2Belgium
26EUCTR2017-000725-12-IT
(EUCTR)
08/01/201809/11/2020A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. - - Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: [Cx601]
TIGENIX S.A.UNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
326Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany
27EUCTR2017-000725-12-FR
(EUCTR)
16/11/201725/11/2019A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
326 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
28NCT03279081
(ClinicalTrials.gov)
September 15, 201721/7/2017Study 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)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 WeeksCrohn's DiseaseDrug: Cx601;Other: PlaceboTigenix S.A.U.NULLRecruiting18 YearsN/AAll554Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;Sweden;United Kingdom
29EUCTR2017-000725-12-BE
(EUCTR)
12/09/201701/06/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden
30EUCTR2017-000725-12-HU
(EUCTR)
07/09/201710/07/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
31EUCTR2017-000725-12-PL
(EUCTR)
03/09/201728/07/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden
32EUCTR2017-000725-12-CZ
(EUCTR)
08/08/201726/04/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Sweden
33EUCTR2017-000725-12-ES
(EUCTR)
26/07/201706/06/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).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. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue
Product Code: Cx601
INN or Proposed INN: To be determined
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
326Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
34NCT02926300
(ClinicalTrials.gov)
November 201511/11/2015Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's DiseaseCrohn's DiseaseBiological: stem cellsKang Stem Biotech Co., Ltd.NULLRecruiting19 Years70 YearsAll24Phase 1/2Korea, Republic of
35NCT02580617
(ClinicalTrials.gov)
April 201515/10/2015A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's DiseaseA Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's DiseaseCrohn's DiseaseBiological: ALLO-ASCAnterogen Co., Ltd.NULLRecruiting18 Years65 YearsAll9Phase 1Korea, Republic of
36NCT02000362
(ClinicalTrials.gov)
August 20147/11/2013Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's DiseaseCrohn's DiseaseBiological: Stem cellsKang Stem Biotech Co., Ltd.NULLRecruiting19 Years70 YearsAll24Phase 1/Phase 2Korea, Republic of
37NCT02676622
(ClinicalTrials.gov)
April 201321/4/2013Autologous Stem Cell Transplant for Refractory Crohn's DiseaseA Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's DiseaseCrohn's DiseaseDrug: mobilization of stem cells to prepare for Leukapheresis;Other: Leukapheresis- Collection of stem cells;Drug: Preparative regimen 4-6 weeks after Leukapheresis;Other: Stem Cell Transplant;Drug: Low-dose IL-2 administrationNationwide Children's HospitalNULLWithdrawn12 Years29 YearsAll0Phase 2NULL
38NCT01540292
(ClinicalTrials.gov)
February 1, 201322/2/2012Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune DisordersMesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune DisordersCrohn's DiseaseBiological: Mesenchymal Stem Cells (MSC)University of LiegeNULLTerminated18 Years75 YearsAll13Phase 1/Phase 2Belgium
39EUCTR2011-006064-43-DE
(EUCTR)
27/09/201217/02/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study. Perianal fistulising Crohn´s disease
MedDRA version: 17.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix S.A.U.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy
40EUCTR2011-006064-43-IT
(EUCTR)
13/09/201205/03/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's diseaseA phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks. ADMIRE-CD study. - ADIMIRE-CD study Perianal fistulising Crohn's disease
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601
Product Code: Cx601
INN or Proposed INN: NA
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs)
CELLERIX S.A.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy
41EUCTR2011-006064-43-NL
(EUCTR)
03/07/201205/07/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease.A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 52 weeks. ADMIRE-CD study. - ADMIRE-CD study Perianal fistulising Crohn´s disease
MedDRA version: 16.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million/ml suspension for injection.
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A. UnipersonalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
208Phase 3France;Belgium;Spain;Austria;Israel;Germany;Netherlands;Italy
42NCT00692939
(ClinicalTrials.gov)
June 26, 20123/6/2008Autologous Stem Cell Transplantation for Crohn's DiseaseAutologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's DiseaseCrohn's DiseaseBiological: autologous CD34-selected peripheral blood stem cells transplant;Drug: Alemtuzumab;Drug: ATG;Drug: Melphalan;Drug: Thiotepa;Drug: Rituximab;Drug: Cyclophosphamide;Drug: G-CSF;Drug: MesnaPaul SzabolcsNULLRecruiting10 Years60 YearsAll20Phase 1/Phase 2United States
43EUCTR2011-006064-43-BE
(EUCTR)
22/06/201221/02/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study. Perianal fistulising Crohn´s desease
MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million/ml suspension for injection.
Product Code: Cx601
INN or Proposed INN: N/A
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A. UnipersonalNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy
44EUCTR2011-006064-43-AT
(EUCTR)
15/05/201205/03/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study. Perianal fistulising Crohn´s disease
MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy
45EUCTR2011-005966-39-BE
(EUCTR)
08/03/201212/12/2011Therapeutic effect of mesenchymal cells in patients suffering from a disease characterized by a severe inflammation and/or in whom the immune system attacks their own tissues.Mesenchymal stem cell therapy for the treatment of severe or refractory inflammatory and/or autoimmune disorders. Crohn's disease
MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.0;Level: PT;Classification code 10064147;Term: Gastrointestinal inflammation;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: mesenchymal stem cells
Product Code: MSC
CHU-ULgNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Belgium
46NCT01233960
(ClinicalTrials.gov)
November 29, 20102/11/2010Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's DiseaseA Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's DiseaseCrohn's DiseaseDrug: adult human mesenchymal stem cellsMesoblast, Inc.NULLCompleted18 Years70 YearsAll73Phase 3United States;Australia;New Zealand
47EUCTR2009-015680-14-NL
(EUCTR)
18/05/201027/07/2010Allogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistulaAllogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistula single or multiple draining perianal fistulas as a result of Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Bone Marrow Derived Mesenchymal Stem cells (MSCs)
Product Code: NA
Leiden University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
Netherlands
48NCT00999115
(ClinicalTrials.gov)
September 200920/10/2009Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn`s Disease (ALOREVA)Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s DiseaseRectovaginal Fistula;Crohn DiseaseDrug: Expanded allogenic adipose-derived adult stem cellsFundacion para la Investigacion Biomedica del Hospital Universitario la PazNULLCompleted18 YearsN/AFemale10Phase 1/Phase 2Spain
49NCT01372969
(ClinicalTrials.gov)
June 200930/8/2010Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.Crohn's Disease;Anal FistulaDrug: Cx601Tigenix S.A.U.NULLCompleted18 YearsN/AAll24Phase 1/Phase 2Spain
50EUCTR2008-004286-25-DE
(EUCTR)
28/04/200921/08/2008Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.FATT 2: Fistula Advanced Therapy Trial (II) - FATT IIRandomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.FATT 2: Fistula Advanced Therapy Trial (II) - FATT II Complex perianal fistula in perianal Crohn´s disease
MedDRA version: 9;Level: LLT;Classification code 10002156;Term: Anal fistula
Product Name: ASCs: Adipose derived Stem Cells
Product Code: Cx401
INN or Proposed INN: ASCs
Other descriptive name: Suspension of adipose derived autologous adult stem cells
CELLERIX S.A.NULLNot RecruitingFemale: yes
Male: yes
196Phase 3Czech Republic;Germany;Netherlands;Belgium;Spain;Austria
51EUCTR2008-004286-25-BE
(EUCTR)
30/03/200911/09/2008Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease. FATT 2: Fistula Advanced Therapy Trial (II) - FATT IIRandomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease. FATT 2: Fistula Advanced Therapy Trial (II) - FATT II Complex perianal fistula in perianal Crohn´s disease
MedDRA version: 9;Level: LLT;Classification code 10002156;Term: Anal fistula
Product Name: ASCs: Adipose derived Stem Cells
Product Code: Cx401
INN or Proposed INN: ASCs
Other descriptive name: Suspension of adipose derived autologous adult stem cells
CELLERIX S.A.NULLNot RecruitingFemale: yes
Male: yes
196Phase 3Czech Republic;Germany;Netherlands;Belgium;Spain;Austria
52NCT01378390
(ClinicalTrials.gov)
December 200821/6/2011Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's DiseaseRandomized, Single-blind, Placebo Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Expanded Autologous Adipose-derived Stem Cells (ASCs) (CX-401), for Treatment of Complex Perianal Fistulas in Perianal Crohn's DiseaseComplex Perianal Fistula;Crohn DiseaseDrug: Expanded autologous adipose-derived adult stem cells (eASCs);Drug: PlaceboTigenix S.A.U.NULLTerminated18 YearsN/AAll56Phase 3Austria;Netherlands;Spain
53NCT00482092
(ClinicalTrials.gov)
September 17, 200730/5/2007Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's DiseaseA Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's DiseaseCrohn's DiseaseDrug: Prochymal®;Drug: PlaceboMesoblast, Inc.NULLCompleted18 Years70 YearsAll330Phase 3United States;Australia;Canada;New Zealand
54NCT00543374
(ClinicalTrials.gov)
September 17, 200711/10/2007Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's DiseaseA Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: PROCHYMAL adult human mesenchymal stem cellsMesoblast, Inc.NULLCompleted18 Years70 YearsAll98Phase 3United States;Canada
55NCT00294112
(ClinicalTrials.gov)
March 13, 200617/2/2006Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's DiseaseA Phase II, Open-label, Randomized Study to Evaluate the Safety and Efficacy of PROCHYMAL™ IBD (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects Experiencing Moderate-to-severe Crohn's Disease That is Refractory to Steroids and Immune SuppressantsCrohn's DiseaseDrug: Prochymal™ adult human mesenchymal stem cells;Drug: adult human mesenchymal stem cellsMesoblast, Inc.NULLCompleted18 Years70 YearsAll10Phase 2United States
56EUCTR2020-003193-48-PL
(EUCTR)
13/10/2020A Phase 3 Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease.A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel inthe Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease over aPeriod of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks. - Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Crohn’s Disease. Complex Perianal Fistulas in Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Darvadstrocel
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Takeda Development Center Americas, Inc.NULLNAFemale: yes
Male: yes
20Phase 3Poland;Israel;Netherlands;Japan