Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病23

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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gender
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PhaseCountries
1EUCTR2017-000725-12-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
2EUCTR2017-000725-12-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
3EUCTR2020-003193-48-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
4EUCTR2019-000333-39-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
5EUCTR2017-002491-10-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
6EUCTR2017-002491-10-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
7EUCTR2017-002491-10-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
8EUCTR2017-002491-10-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
9EUCTR2019-000333-39-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
10EUCTR2017-002491-10-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
11EUCTR2019-000333-39-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)
Takeda Development Center Americas, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
12EUCTR2017-000725-12-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
13EUCTR2017-000725-12-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
14EUCTR2017-000725-12-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
15EUCTR2017-000725-12-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
16EUCTR2017-000725-12-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
17EUCTR2017-000725-12-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
18EUCTR2017-000725-12-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
19EUCTR2017-000725-12-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
20EUCTR2011-006064-43-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
21EUCTR2011-006064-43-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
22EUCTR2011-006064-43-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
23EUCTR2020-003193-48-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