Stem Cells ( DrugBank: - )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 23 |
| 4 | 原発性側索硬化症 | 1 |
| 96 | クローン病 | 56 |
| 113 | 筋ジストロフィー | 4 |
2. 筋萎縮性側索硬化症
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
| 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 | NCT04849065 (ClinicalTrials.gov) | May 1, 2021 | 15/4/2021 | Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral Sclerosis | Clinical Trial in Phase II of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis. | ALS (Amyotrophic Lateral Sclerosis) | Drug: MNC (Mononuclear cells);Drug: Placebo / Saline | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | NULL | Not yet recruiting | 18 Years | 70 Years | All | 100 | Phase 2 | Spain |
| 2 | NCT04651855 (ClinicalTrials.gov) | December 2, 2020 | 30/9/2020 | The Evaluation of the Effect of Mesenchymal Stem Cells on the Immune System of Patients With ALS | The Evaluation of the Effect of Wharton's Jelly Mesenchymal Stem Cells (WJMSCs) on the Immune System of Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Mesenchymal stem cells isolated from Wharton's jelly | Polski Bank Komorek Macierzystych JSC (PBKM) | The National Centre for Research and Development | Recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | Poland |
| 3 | EUCTR2018-004171-12-PL (EUCTR) | 22/07/2020 | 05/09/2019 | The evaluation of the effect of Wharton’s Jelly Mesenchymal Stem Cells (WJMSCs) on the immune system of patients with Amyotrophic Lateral Sclerosis (ALS) | The evaluation of the effect of Wharton’s Jelly Mesenchymal Stem Cells (WJMSCs) on the immune system of patients with Amyotrophic Lateral Sclerosis (ALS) - ALSTEM | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FamC-1 INN or Proposed INN: WHARTON’S JELLY-DERIVED MESENCHYMAL STEM CELLS Other descriptive name: WHARTON’S JELLY-DERIVED MESENCHYMAL STEM CELLS | Polski Bank Komórek Macierzystych JSC (PBKM) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Poland | ||
| 4 | EUCTR2019-002302-46-ES (EUCTR) | 23/10/2019 | 09/08/2019 | Phase II clinical trial of intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosis | Phase II clinical trial of intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosis | Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: autologous adult bone marrow mononuclear cells (BM-MNC) unexpanded INN or Proposed INN: autologous adult bone marrow mononuclear cells unexpanded Other descriptive name: autologous adult bone marrow mononuclear cells unexpanded | Fundación para la Formación e Investigación Sanitarias de la Región de Murcia | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain | ||
| 5 | NCT03482050 (ClinicalTrials.gov) | April 12, 2018 | 14/3/2018 | A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase I/IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Theraputic Effects of Transplantation of Astrocytes Derived From Human Embryonic Stem Cells (hESC), in Patients With Amyotrophic Lateral Sclerosis (ALS) | ALS (Amyotrophic Lateral Sclerosis) | Biological: AstroRx | Kadimastem | NULL | Completed | 18 Years | 70 Years | All | 16 | Phase 1/Phase 2 | Israel |
| 6 | NCT03280056 (ClinicalTrials.gov) | August 28, 2017 | 29/8/2017 | Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients | A Phase 3, Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Participants With ALS | Amyotrophic Lateral Sclerosis (ALS) | Biological: NurOwn® (MSC-NTF cells);Other: Placebo;Other: Bone Marrow aspiration | Brainstorm-Cell Therapeutics | California Institute for Regenerative Medicine (CIRM) | Completed | 18 Years | 60 Years | All | 263 | Phase 3 | United States |
| 7 | NCT03067857 (ClinicalTrials.gov) | September 2016 | 25/2/2017 | Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease | Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease | Motor Neuron Disease;Amyotrophic Lateral Sclerosis;Primary Lateral Sclerosis;Progressive Muscular Atrophy;Progressive Bulbar Palsies | Biological: Stem Cells | Stem Cells Arabia | NULL | Unknown status | 24 Years | 70 Years | All | 40 | Phase 1/Phase 2 | NULL |
| 8 | NCT04821479 (ClinicalTrials.gov) | January 1, 2016 | 19/10/2020 | Repeated Mesenchymal Stem Cell Injections in ALS | Safety and Clinical Effects of Repeated Intrathecal Injections of Autologous Mesenchymal Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Biological: Mesenchymal stem cells (MSC) | Hadassah Medical Organization | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 1/Phase 2 | NULL |
| 9 | NCT02881489 (ClinicalTrials.gov) | November 2015 | 22/4/2016 | Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Patients With Amyotrophic Lateral Sclerosis | Evaluation of Mesenchymal Stem Cell Culturing Protocols in the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Other: Biological: Cell-based therapy | University of Warmia and Mazury | NULL | Enrolling by invitation | 18 Years | 65 Years | Both | 30 | Phase 1 | NULL |
| 10 | NCT02881476 (ClinicalTrials.gov) | November 2015 | 22/4/2016 | Therapeutic Treatment of Amyotrophic Lateral Sclerosis | Application of Wharton's Jelly-derived Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Other: Biological: Cell-based therapy | University of Warmia and Mazury | NULL | Enrolling by invitation | 18 Years | 65 Years | Both | 30 | Phase 1 | NULL |
| 11 | NCT02116634 (ClinicalTrials.gov) | May 2015 | 6/4/2014 | Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis | Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients | Amyotrophic Lateral Sclerosis | Biological: mesenchymal stem cell | Alzahra Hospital, Iran | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 1/Phase 2 | Iran, Islamic Republic of |
| 12 | NCT02987413 (ClinicalTrials.gov) | April 28, 2015 | 1/7/2016 | Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis Patients | Safety and Efficacy of Mesenchymal Stem Cells Escalated Application in Amyotrophic Lateral Sclerosis Patients: Study Design of a Phase I Trial | Motor Neuron Disease | Biological: Autologous Mesenchymal stem cells (MSCs) | Hospital e Maternidade Dr. Christóvão da Gama | IEP São Lucas - Instituto de Ensino e Pesquisa;Clinica Jordy Sinapse;TECHLIFE - Centro de Tecnologia Celular | Completed | 18 Years | N/A | All | 3 | Phase 1 | Brazil |
| 13 | NCT02286011 (ClinicalTrials.gov) | November 2014 | 24/10/2014 | Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis | Phase I Clinical Trial on Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis. | ALS (Amyotrophic Lateral Sclerosis) | Biological: MNC (Mononuclear cells);Other: Saline | Red de Terapia Celular | Spanish National Health System;Hospital Universitario Virgen de la Arrixaca;Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia;Public Health Service, Murcia;Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca | Active, not recruiting | 18 Years | 70 Years | All | 20 | Phase 1 | Spain |
| 14 | NCT02492516 (ClinicalTrials.gov) | September 2014 | 24/6/2015 | Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS | Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS | Amyotrophic Lateral Sclerosis | Biological: mesenchymal stem cells | Royan Institute | NULL | Completed | 18 Years | 55 Years | All | 19 | Phase 1 | Iran, Islamic Republic of |
| 15 | EUCTR2011-004801-25-ES (EUCTR) | 16/07/2014 | 11/01/2013 | CLINICAL TRIAL ON THE USE OF BONE MARROW OWN PATIENT'S WITH AMYOTROPHIC LATERAL SCLEROSIS | A PHASE I/II CLINICAL TRIAL OF THE BONE MARROW'S AUTOLOGOUS STEM CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS | amyotrophic lateral sclerosis MedDRA version: 15.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: células troncales hematopoyéticas autólogas adultas extraidas de médula ósea INN or Proposed INN: autologous bone marrow mononucleated cells Other descriptive name: autologous bone marrow mononucleated cells | Fundación Sanitaria para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Spain | |||
| 16 | NCT02017912 (ClinicalTrials.gov) | May 2014 | 17/12/2013 | Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS | A Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate Safety and Efficacy of Transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (MSC-NTF) in Patients With ALS | Amyotrophic Lateral Sclerosis (ALS) | Biological: Autologous MSC-NTF cells;Biological: Placebo | Brainstorm-Cell Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 48 | Phase 2 | United States |
| 17 | EUCTR2011-006254-85-ES (EUCTR) | 08/02/2013 | 09/08/2012 | Clinical trial to value the safety and efficacy of administration of stem cells derived from own patient for the treatment of Amyotrophic Lateral Sclerosis (ALS). | Placebo controlled, randomized and triple blind multicentric phase I/II clinical trial to evaluate the safety, feasibility and valoration of efficacy trends of intravenous administration of three doses of autologous adipose derived autologous mesenchymal stem cells (CeTMAd) in moderate/severe ALS patients. | Amyotrophic lateral sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Células madre mesenquimales de tejido adiposo autólogo INN or Proposed INN: NA Other descriptive name: Células Mesenquimales de tejido adiposo | FUNDACIÓN PROGRESO Y SALUD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Spain | |||
| 18 | NCT01933321 (ClinicalTrials.gov) | September 2012 | 28/9/2012 | Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS) | Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Biological: Intrathecal autologous stem cell | Hospital Universitario Dr. Jose E. Gonzalez | NULL | Completed | 18 Years | N/A | Both | 14 | Phase 2/Phase 3 | Mexico |
| 19 | NCT01609283 (ClinicalTrials.gov) | May 2012 | 18/5/2012 | A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis | A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: autologous mesenchymal stem cells | Mayo Clinic | NULL | Completed | 18 Years | N/A | All | 27 | Phase 1 | United States |
| 20 | EUCTR2011-000362-35-CZ (EUCTR) | 29/03/2012 | 05/04/2011 | Safety and Efficacy of Stem Cell Therapy of Motor Neuron Disease. | A Prospective, Non-randomized, Open Label Study to Assess the Safety and the Efficacy of Autologous Multipotent Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral Sclerosis. - AMSC in ALS | Amyotrophic lateral sclerosis MedDRA version: 17.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Suspension of human autologous MSC 3P in 1,5 ml Product Code: AMSC INN or Proposed INN: Human autologous mesenchymal stem cells | Bioinova, s.r.o. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Czech Republic | ||
| 21 | NCT01640067 (ClinicalTrials.gov) | December 2011 | 9/7/2012 | Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS) | Intra-spinal Cord Delivery of Human Neural Stem Cells in ALS Patients: Proposal for a Phase I Study/ Trapianto Intramidollare di Cellule Staminali Neurali Umane Come Terapia Putativa Per la SLA: Proposta di un Trial Clinico di Fase I | Amyotrophic Lateral Sclerosis | Biological: Human Neural Stem Cells | Azienda Ospedaliera Santa Maria, Terni, Italy | Azienda Ospedaliero Universitaria Maggiore della Carita;Università di Padova Italy | Completed | 20 Years | 75 Years | Both | 18 | Phase 1 | Italy |
| 22 | NCT01142856 (ClinicalTrials.gov) | June 2010 | 10/6/2010 | Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS) | A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Biological: autologous mesenchymal stem cells | Mayo Clinic | NULL | Completed | 18 Years | N/A | Both | 1 | Phase 1 | United States |
| 23 | NCT01082653 (ClinicalTrials.gov) | March 2010 | 1/3/2010 | Safety/Efficacy Study for the Treatment of Amyotrophic Lateral Sclerosis | Phase I, Single Center, Prospective, Non-randomized, Open Label, Safety/Efficacy Study of the Infusion of Autologous Bone Marrow-derived Stem Cells, in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: autologous bone marrow-derived stem cells | TCA Cellular Therapy | NULL | Suspended | 18 Years | 80 Years | Both | 6 | Phase 1 | United States |
4. 原発性側索硬化症
臨床試験数 : 7 / 薬物数 : 17 - (DrugBank : 9) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 32
| 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 | NCT03067857 (ClinicalTrials.gov) | September 2016 | 25/2/2017 | Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease | Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease | Motor Neuron Disease;Amyotrophic Lateral Sclerosis;Primary Lateral Sclerosis;Progressive Muscular Atrophy;Progressive Bulbar Palsies | Biological: Stem Cells | Stem Cells Arabia | NULL | Unknown status | 24 Years | 70 Years | All | 40 | Phase 1/Phase 2 | NULL |
96. クローン病
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | 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 | Not yet recruiting | 18 Years | 70 Years | All | 40 | N/A | China |
| 2 | 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 |
| 3 | NCT05075811 (ClinicalTrials.gov) | January 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. | Not yet recruiting | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | United States |
| 4 | 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 |
| 5 | 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 | ||
| 6 | 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 |
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 |
| 10 | 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 |
| 11 | 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 | ||
| 12 | 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 |
| 13 | 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 |
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 |
| 22 | 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) | Millennium Pharmaceuticals, Inc (MPI) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 |
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | NCT03279081 (ClinicalTrials.gov) | September 15, 2017 | 21/7/2017 | 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 Participants With Crohn's Disease (CD) | A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks | Crohn's Disease | Drug: Cx601;Other: Placebo | Tigenix S.A.U. | NULL | Recruiting | 18 Years | N/A | All | 554 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;Sweden;United Kingdom |
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 |
| 35 | 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 |
| 36 | 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 |
| 37 | 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 |
| 38 | 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 |
| 39 | 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 | ||
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | 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 |
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | 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 | |||
| 46 | 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 |
| 47 | 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 | ||||
| 48 | 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 |
| 49 | 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 |
| 50 | 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 | ||
| 51 | 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 | ||
| 52 | 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 |
| 53 | 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 |
| 54 | 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 |
| 55 | 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 |
| 56 | 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 |
113. 筋ジストロフィー
臨床試験数 : 622 / 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
| 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 | NCT03067831 (ClinicalTrials.gov) | September 2015 | 25/2/2017 | Bone Marrow-Derived Autologous Stem Cells for the Treatment of Duchenne Muscular Dystrophy | Safety and Efficacy of Purified Autologous Bone Marrow-Derived Stem Cell Therapy for Patients With Duchenne Muscular Dystrophy. | Duchenne Muscular Dystrophy | Biological: Stem Cells | Stem Cells Arabia | NULL | Recruiting | 4 Years | 25 Years | All | 20 | Phase 1/Phase 2 | Jordan |
| 2 | NCT02235844 (ClinicalTrials.gov) | September 2014 | 8/9/2014 | Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for a Single Male Patient With Duchenne Muscular Dystrophy (DMD) | Allogeneic Transplantation of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for a Single Male Patient With Duchenne Muscular Dystrophy (DMD) | Duchenne's Muscular Dystrophy | Biological: Umbilical Cord Mesenchymal Stem Cells | Allergy and Asthma Consultants, Wichita, Kansas | Aidan Foundation;Neil H. Riordan PhD | Completed | 28 Years | 31 Years | Male | 1 | Phase 1 | United States |
| 3 | NCT02285673 (ClinicalTrials.gov) | November 2013 | 5/11/2014 | Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy | Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy: Phase 1/2 Study | Duchenne Muscular Dystrophy | Biological: Umbilical Cord Mesenchymal Stem Cell | Acibadem University | NULL | Recruiting | 7 Years | 20 Years | Male | 10 | Phase 1/Phase 2 | Turkey |
| 4 | NCT01610440 (ClinicalTrials.gov) | October 2011 | 21/5/2012 | Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Duchenne Muscular Dystrophy | Phase I/II Study of Stem Cell Therapy in Patients With Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Biological: human umbilical cord mesenchymal stem cells | Shenzhen Beike Bio-Technology Co., Ltd. | The Second Affiliated Hospital of Kunming Medical University | Recruiting | 5 Years | 12 Years | Both | 15 | Phase 1/Phase 2 | China |