Allogenic eascs 5 million/ml suspension for injection. (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 | 2 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-006064-43-NL (EUCTR) | 03/07/2012 | 05/07/2012 | Study 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. Unipersonal | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Germany;Netherlands;Italy | ||
| 2 | EUCTR2011-006064-43-BE (EUCTR) | 22/06/2012 | 21/02/2012 | Study 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. Unipersonal | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy |