2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 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 | NCT04681118 (ClinicalTrials.gov) | March 24, 2021 | 18/12/2020 | Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS | Intermediate-size Patient Population Expanded Access Protocol: Repeated Administration of Nurown® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) for the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Biological: NurOwn (MSC-NTF cells) | Brainstorm-Cell Therapeutics | NULL | No longer available | 18 Years | 63 Years | All | United States | ||
| 3 | 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) | National Center for Research and Development, Poland | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | Poland |
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 | |||
| 15 | 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 |
| 16 | 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 | |||
| 17 | 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 |
| 18 | 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 |
| 19 | 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 | ||
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |