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


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

  
10 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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
3EUCTR2017-000725-12-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
4EUCTR2017-000725-12-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
5EUCTR2017-000725-12-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
6EUCTR2017-000725-12-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
7EUCTR2017-000725-12-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
8EUCTR2017-000725-12-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
9EUCTR2017-000725-12-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
10EUCTR2017-000725-12-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