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
| 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 | NCT05521672 (ClinicalTrials.gov) | October 24, 2022 | 22/8/2022 | Clinical Trial to Evaluate if the Laparoscopic Administration of Cells Derived From the Fatty Tissue Can Improve the Inflammatory Stenosis in Patient With Crohn's Disease | Clinical Trial Phase IIa to Evaluate the Safety and Effectiveness of Treatment With Fat-derived Mesenchymal Allogenic Mesenchymal Troncal Cells in Patients With Single Inflammatory Stenosis in the Context of Crohn's Disease. | Stenosis; Bowel;Crohn Disease | Drug: Adipose derived allogenic mesenchymal stem cells (adAMSC) | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Effice Servicios Para la Investigacion S.L. | Recruiting | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | Spain |
| 2 | NCT05407766 (ClinicalTrials.gov) | August 2022 | 9/5/2022 | Mesenchymal Stem Cells (MSCs) for Perianal Fistula | A Phase I Safety Study of Allogeneic Bone Marrow Derived MSCs for Refractory Perianal Fistulizing Crohn's Disease | Rectal Fistula | Biological: OSSM-001;Other: Placebo | Ossium Health, Inc. | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | NULL |
| 3 | EUCTR2021-006068-26-ES (EUCTR) | 27/07/2022 | 24/03/2022 | Clinical trial to evaluate if the laparoscopic administration of cells derived from the fatty tissue can improve the inflammatory stenosis in patient with Crohn's disease. | CLINICAL TRIAL PHASE IIa TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TREATMENT WITH FAT-DERIVED MESENCHYMAL ALLOGENIC MESENCHYMAL TRONCAL CELLS IN PATIENTS WITH SINGLE INFLAMMATORY STENOSIS IN THE CONTEXT OF CROHN'S DISEASE. | Inflammatory stenosis in patient with Crohn's disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: allogenic mesenchymal stem cell isolated from adipose tissue INN or Proposed INN: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED Other descriptive name: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED | FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Spain | ||
| 4 | NCT05578508 (ClinicalTrials.gov) | April 2022 | 1/11/2019 | Stem Cells for the Treatment of Pouchitis | A Phase I Study of Bone Marrow Derived Mesenchymal Stem Cells (MSCs) for the Treatment of Medically Refractory Pouchitis | Pouchitis;Crohn's Disease;Ulcerative Colitis Chronic;Inflammatory Bowel Diseases;Pouch, Ileal | Drug: Mesenchymal Stem Cells (MSCs) | The Cleveland Clinic | Case Western Reserve University | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 5 | NCT05262829 (ClinicalTrials.gov) | February 28, 2022 | 8/2/2022 | Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate and Severe Crohn's Disease | A Single-arm, Open-label Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Moderate to Severe Crohn's Disease | Crohn Disease | Biological: Human Umbilical Cord Mesenchymal Stem Cells | Shanghai East Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 40 | N/A | China |
| 6 | NCT05075811 (ClinicalTrials.gov) | February 1, 2022 | 28/9/2021 | Study of Ossium Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in the Setting of Crohn's Disease | A 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 Pouch | Pouch, Ileal;Fistula | Drug: Ossium vBM-MSC;Other: Placebo | Amy Lightner | Ossium Health, Inc. | Recruiting | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | United States |
| 7 | NCT05039411 (ClinicalTrials.gov) | January 1, 2022 | 1/9/2021 | Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease | A Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's Disease | Perianal Fistula Due to Crohn's Disease;Fistula in Ano | Biological: Human umbilical cord mesenchymal stem cells (UC-MSCs) | CryoCord Sdn Bhd | University of Malaya | Not yet recruiting | 18 Years | N/A | All | 7 | Phase 1 | Malaysia |
| 8 | NCT04073472 (ClinicalTrials.gov) | June 1, 2021 | 23/8/2019 | Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's | A 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 Pouch | Crohn's Disease;Fistula;Anal Fistula;Pouch, Ileal;Pouches, Ileoanal | Drug: mesenchymal stem cells (MSCs) | The Cleveland Clinic | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 9 | EUCTR2017-000725-12-DK (EUCTR) | 07/04/2021 | 14/10/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 10 | NCT04791878 (ClinicalTrials.gov) | April 1, 2021 | 6/3/2021 | Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease | A Phase I Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease | Perianal Fistula Due to Crohn's Disease (Disorder) | Drug: Mesenchymal stem cells | Amy Lightner | NULL | Recruiting | 13 Years | 17 Years | All | 10 | Phase 1 | United States |
| 11 | EUCTR2017-000725-12-SE (EUCTR) | 30/03/2021 | 20/08/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 12 | EUCTR2020-003193-48-NL (EUCTR) | 25/01/2021 | 21/11/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | Spain;Poland;Israel;Netherlands;Italy;Japan | ||
| 13 | NCT04519671 (ClinicalTrials.gov) | November 19, 2020 | 17/8/2020 | Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease | A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease | Perianal Crohn Disease;Perianal Fistula;Crohn Disease | Drug: Mesenchymal Stem Cells;Other: Placebo | Amy Lightner | NULL | Recruiting | 18 Years | 75 Years | All | 40 | Phase 1/Phase 2 | United States |
| 14 | NCT04939337 (ClinicalTrials.gov) | November 12, 2020 | 10/6/2021 | A 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 Disease | Drug: TH-SC01 | Jinling Hospital, China | Jiangsu Topcel-KH Pharmaceutical Co., Ltd | Enrolling by invitation | 18 Years | 70 Years | All | 24 | Phase 1 | China |
| 15 | EUCTR2019-000333-39-FR (EUCTR) | 07/11/2020 | 04/10/2019 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A 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) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 16 | NCT04519697 (ClinicalTrials.gov) | October 28, 2020 | 17/8/2020 | Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease | A 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; Fistula | Drug: Mesenchymal Stem Cells;Other: Placebo | Amy Lightner | NULL | Recruiting | 18 Years | 75 Years | Female | 40 | Phase 1/Phase 2 | United States |
| 17 | NCT04519684 (ClinicalTrials.gov) | October 28, 2020 | 17/8/2020 | Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's Disease | A 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 Pouch | Ileal Pouch;Crohn Disease | Drug: Mesenchymal stem cells;Other: Placebo | Amy Lightner | NULL | Recruiting | 18 Years | 75 Years | All | 40 | Phase 1/Phase 2 | United States |
| 18 | EUCTR2017-002491-10-AT (EUCTR) | 19/08/2020 | 11/05/2020 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czechia;Czech Republic;Spain;Austria;Israel;Germany | ||
| 19 | EUCTR2017-002491-10-FR (EUCTR) | 17/07/2020 | 09/03/2020 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization 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) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czech Republic;Spain;Austria;Germany;United Kingdom | ||
| 20 | EUCTR2017-002491-10-DE (EUCTR) | 22/06/2020 | 09/03/2020 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czechia;Czech Republic;Spain;Austria;Israel;Germany | ||
| 21 | EUCTR2017-002491-10-ES (EUCTR) | 03/06/2020 | 06/03/2020 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization 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) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czech Republic;Spain;Austria;Germany;United Kingdom | ||
| 22 | EUCTR2019-000333-39-BE (EUCTR) | 04/05/2020 | 21/01/2020 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistula | A 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, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany | ||
| 23 | EUCTR2017-002491-10-CZ (EUCTR) | 10/03/2020 | 27/11/2019 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization 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) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom | ||
| 24 | EUCTR2019-000333-39-IT (EUCTR) | 09/12/2019 | 24/05/2021 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany | ||
| 25 | NCT02677350 (ClinicalTrials.gov) | December 1, 2019 | 1/2/2016 | AlloGeneic 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 Cells | Drug: Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs) | Joshua M Hare | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1 | United States |
| 26 | EUCTR2019-000333-39-CZ (EUCTR) | 15/10/2019 | 03/09/2019 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A 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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 27 | EUCTR2017-000725-12-DE (EUCTR) | 17/07/2019 | 28/02/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 28 | EUCTR2017-000725-12-GB (EUCTR) | 17/04/2019 | 22/10/2018 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 29 | NCT03901235 (ClinicalTrials.gov) | January 15, 2018 | 4/3/2019 | MSC Intratissular Injection in Crohn Disease Patients | Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells | Efficacy and Safety | Biological: Mesenchymal Stromal Cells | University of Liege | Centre Hospitalier Universitaire de Liege | Recruiting | 18 Years | N/A | All | 60 | Phase 1/Phase 2 | Belgium |
| 30 | EUCTR2017-000725-12-IT (EUCTR) | 08/01/2018 | 09/11/2020 | A 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.U | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 326 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany | ||
| 31 | EUCTR2017-000725-12-FR (EUCTR) | 16/11/2017 | 25/11/2019 | A 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. | NULL | Authorised-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): no | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 32 | EUCTR2017-000725-12-BE (EUCTR) | 12/09/2017 | 01/06/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 33 | EUCTR2017-000725-12-HU (EUCTR) | 07/09/2017 | 10/07/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 34 | EUCTR2017-000725-12-PL (EUCTR) | 03/09/2017 | 28/07/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden | ||
| 35 | EUCTR2017-000725-12-CZ (EUCTR) | 08/08/2017 | 26/04/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 36 | EUCTR2017-000725-12-ES (EUCTR) | 26/07/2017 | 06/06/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 326 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 37 | NCT02926300 (ClinicalTrials.gov) | November 2015 | 11/11/2015 | Long-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 Disease | Crohn's Disease | Biological: stem cells | Kang Stem Biotech Co., Ltd. | NULL | Recruiting | 19 Years | 70 Years | All | 24 | Phase 1/2 | Korea, Republic of |
| 38 | NCT02580617 (ClinicalTrials.gov) | April 2015 | 15/10/2015 | A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's Disease | A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's Disease | Crohn's Disease | Biological: ALLO-ASC | Anterogen Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 9 | Phase 1 | Korea, Republic of |
| 39 | NCT02000362 (ClinicalTrials.gov) | August 2014 | 7/11/2013 | Safety 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 Disease | Crohn's Disease | Biological: Stem cells | Kang Stem Biotech Co., Ltd. | NULL | Recruiting | 19 Years | 70 Years | All | 24 | Phase 1/Phase 2 | Korea, Republic of |
| 40 | NCT02676622 (ClinicalTrials.gov) | April 2013 | 21/4/2013 | Autologous Stem Cell Transplant for Refractory Crohn's Disease | A Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's Disease | Crohn's Disease | Drug: 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 administration | Nationwide Children's Hospital | NULL | Withdrawn | 12 Years | 29 Years | All | 0 | Phase 2 | NULL |
| 41 | NCT01540292 (ClinicalTrials.gov) | February 1, 2013 | 22/2/2012 | Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders | Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders | Crohn's Disease | Biological: Mesenchymal Stem Cells (MSC) | University of Liege | NULL | Terminated | 18 Years | 75 Years | All | 13 | Phase 1/Phase 2 | Belgium |
| 42 | EUCTR2011-006064-43-DE (EUCTR) | 27/09/2012 | 17/02/2012 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy | ||
| 43 | EUCTR2011-006064-43-IT (EUCTR) | 13/09/2012 | 05/03/2012 | 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. 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. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy | ||
| 44 | 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 | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Austria;Israel;Germany;Netherlands;Italy | ||
| 45 | NCT00692939 (ClinicalTrials.gov) | June 26, 2012 | 3/6/2008 | Autologous Stem Cell Transplantation for Crohn's Disease | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease | Crohn's Disease | Biological: autologous CD34-selected peripheral blood stem cells transplant;Drug: Alemtuzumab;Drug: ATG;Drug: Melphalan;Drug: Thiotepa;Drug: Rituximab;Drug: Cyclophosphamide;Drug: G-CSF;Drug: Mesna | Paul Szabolcs | NULL | Recruiting | 10 Years | 60 Years | All | 20 | Phase 1/Phase 2 | United States |
| 46 | 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 | ||
| 47 | EUCTR2011-006064-43-AT (EUCTR) | 15/05/2012 | 05/03/2012 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy | ||
| 48 | EUCTR2011-005966-39-BE (EUCTR) | 08/03/2012 | 12/12/2011 | Therapeutic 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-ULg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Belgium | |||
| 49 | NCT01233960 (ClinicalTrials.gov) | November 29, 2010 | 2/11/2010 | Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease | A 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 Disease | Crohn's Disease | Drug: adult human mesenchymal stem cells | Mesoblast, Inc. | NULL | Completed | 18 Years | 70 Years | All | 73 | Phase 3 | United States;Australia;New Zealand |
| 50 | EUCTR2009-015680-14-NL (EUCTR) | 18/05/2010 | 27/07/2010 | Allogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistula | Allogeneic 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 Center | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 51 | NCT00999115 (ClinicalTrials.gov) | September 2009 | 20/10/2009 | Allogenic 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 Disease | Rectovaginal Fistula;Crohn Disease | Drug: Expanded allogenic adipose-derived adult stem cells | Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz | NULL | Completed | 18 Years | N/A | Female | 10 | Phase 1/Phase 2 | Spain |
| 52 | NCT01372969 (ClinicalTrials.gov) | June 2009 | 30/8/2010 | 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. | 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 Fistula | Drug: Cx601 | Tigenix S.A.U. | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1/Phase 2 | Spain |
| 53 | EUCTR2008-004286-25-DE (EUCTR) | 28/04/2009 | 21/08/2008 | Randomized, 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 | Randomized, 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. | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 3 | Czech Republic;Germany;Netherlands;Belgium;Spain;Austria | ||
| 54 | EUCTR2008-004286-25-BE (EUCTR) | 30/03/2009 | 11/09/2008 | Randomized, 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 | Randomized, 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. | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 3 | Czech Republic;Germany;Netherlands;Belgium;Spain;Austria | ||
| 55 | NCT01378390 (ClinicalTrials.gov) | December 2008 | 21/6/2011 | Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease | Randomized, 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 Disease | Complex Perianal Fistula;Crohn Disease | Drug: Expanded autologous adipose-derived adult stem cells (eASCs);Drug: Placebo | Tigenix S.A.U. | NULL | Terminated | 18 Years | N/A | All | 56 | Phase 3 | Austria;Netherlands;Spain |
| 56 | NCT00543374 (ClinicalTrials.gov) | September 17, 2007 | 11/10/2007 | Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease | A 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 Disease | Crohn's Disease | Drug: Placebo;Drug: PROCHYMAL adult human mesenchymal stem cells | Mesoblast, Inc. | NULL | Completed | 18 Years | 70 Years | All | 98 | Phase 3 | United States;Canada |
| 57 | NCT00482092 (ClinicalTrials.gov) | September 17, 2007 | 30/5/2007 | Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease | A 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 Disease | Crohn's Disease | Drug: Prochymal®;Drug: Placebo | Mesoblast, Inc. | NULL | Completed | 18 Years | 70 Years | All | 330 | Phase 3 | United States;Australia;Canada;New Zealand |
| 58 | NCT00294112 (ClinicalTrials.gov) | March 13, 2006 | 17/2/2006 | Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease | A 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 Suppressants | Crohn's Disease | Drug: Prochymal™ adult human mesenchymal stem cells;Drug: adult human mesenchymal stem cells | Mesoblast, Inc. | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 2 | United States |
| 59 | EUCTR2020-003193-48-PL (EUCTR) | 13/10/2020 | A 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. | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | Poland;Israel;Netherlands;Japan |