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 | 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 | ||
| 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) | National Center for Research and Development, Poland | Active, not 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 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 | |||
| 11 | 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 |
| 12 | 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 | ||
| 13 | 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 |