51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 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 | NCT04380831 (ClinicalTrials.gov) | February 24, 2022 | 30/4/2020 | TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis | Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Radiation: Intensity-Modulated Radiation Therapy;Procedure: Total-Body Irradiation | City of Hope Medical Center | National Cancer Institute (NCI) | Recruiting | 18 Years | 65 Years | All | 15 | Early Phase 1 | United States |
| 2 | EUCTR2019-004718-32-NL (EUCTR) | 09/10/2020 | 09/10/2020 | Stem cell transplantation in diffuse cutaneous systemic sclerosis: upfront therapy or rescue therapy after failure of immunosuppressants? | Upfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial | Diffuse cutaneous systemic sclerosis according to the ACR/EULAR criteria;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Mycophenolate mofetil | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 3 | JPRN-jRCTc071190041 | 04/01/2019 | 09/01/2020 | A clinical trial of autologous stem cell transplantation for severe systemic sclerosis | A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis - A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis | systemic sclerosis | After peripheral blood stem cell mobilization and aphereisi with cyclophosphamide 4 g/m2 and G-CSF, CD34+ cells were enriched by using anti-CD34 immunomagnetic beads. Conditioning was performed using high-dose cyclophosphamide (50 mg/kg) for 4 days, and freeze-thawed CD34+ cells were transplanted. | Akashi Koichi | NULL | Recruiting | >= 16age old | < 65age old | Both | 12 | Phase 2 | Japan |
| 4 | NCT03630211 (ClinicalTrials.gov) | July 31, 2018 | 7/8/2018 | Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc) | Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary Hypertension | Drug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation | Paul Szabolcs | NULL | Recruiting | 16 Years | 70 Years | All | 8 | Phase 2 | United States |
| 5 | NCT01895244 (ClinicalTrials.gov) | September 2012 | 1/7/2013 | Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis | Highdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to Manifestation | Scleroderma;Cardiac Involvement;Autologous Stem Cell Transplantation | Drug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells | University Hospital Tuebingen | NULL | Recruiting | 18 Years | 65 Years | All | 44 | Phase 2 | Germany |
| 6 | NCT01413100 (ClinicalTrials.gov) | September 15, 2011 | 8/8/2011 | Scleroderma Treatment With Autologous Transplant (STAT) Study | A Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic Sclerosis | Systemic Scleroderma | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Biological: Filgrastim;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Plerixafor;Other: Quality-of-Life Assessment;Other: Questionnaire Administration | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Active, not recruiting | N/A | 70 Years | All | 21 | Phase 2 | United States;Canada |
| 7 | JPRN-UMIN000031940 | 2010/09/07 | 28/03/2018 | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis | Systemic sclerosis | Cyclophosphamide 2g/m2, 2 days Harvest of autologous hematopoietic stem cells Cyclophosphamide 50mg/kg, 4 days Transplantation of autologous hematopoietic stem cells | Kyushu University | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 24 | Phase 2 | Japan | |
| 8 | NCT01047072 (ClinicalTrials.gov) | January 2010 | 11/1/2010 | Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis | Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | National Cancer Institute (NCI) | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 2 | United States |
| 9 | EUCTR2006-004598-83-GB (EUCTR) | 22/10/2008 | 24/10/2008 | High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS | High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS | Severe systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Neupogen Product Name: Filgrastim INN or Proposed INN: FILGRASTIM Trade Name: Thymoglobuline Product Name: Thymoglobuline Product Code: rbATG INN or Proposed INN: Anti-Thymocyte Globulin, Rabbit Other descriptive name: ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS Trade Name: Solu-Medrone Product Name: Methylprednisolone INN or Proposed INN: METHYLPREDNISOLONE Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Mesna Product Name: Mesna INN or Proposed INN: MESNA Trade Name: Mesna Product Name: Mesna INN or Proposed INN: MESNA | EBMT (European group for Blood and Marrow Transplantation) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | United Kingdom | |||
| 10 | NCT00684255 (ClinicalTrials.gov) | August 2007 | 22/5/2008 | Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc) | Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc) | Systemic Lupus Erythematosus;Systemic Sclerosis | Procedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: Campath | New York Medical College | NULL | Terminated | 7 Years | 50 Years | All | 1 | Phase 1 | United States |
| 11 | NCT00622895 (ClinicalTrials.gov) | September 1, 2006 | 22/2/2008 | Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis | Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma;Severe Systemic Sclerosis | Drug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsy | Fred Hutchinson Cancer Research Center | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | N/A | 70 Years | All | 3 | Phase 1/Phase 2 | United States |
| 12 | NCT00278525 (ClinicalTrials.gov) | September 2005 | 15/1/2006 | Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma | Trial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized Trial | SYSTEMIC SCLERODERMA | Drug: standard of care;Procedure: stem cell transplantation | Northwestern University | NULL | Completed | N/A | 60 Years | All | 19 | Phase 2 | United States |
| 13 | NCT00282425 (ClinicalTrials.gov) | May 2005 | 24/1/2006 | Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis | Scleroderma | Biological: Hematopoietic stem cell transplantation | Richard Burt, MD | NULL | Terminated | 18 Years | 55 Years | Both | 8 | Phase 1 | United States |
| 14 | NCT00058578 (ClinicalTrials.gov) | June 1999 | 8/4/2003 | Stem Cell Transplant to Treat Patients With Systemic Sclerosis | Autologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Procedure: Leukopheresis;Procedure: Total Body Irradiation | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Completed | 18 Years | 65 Years | All | 24 | Phase 1 | United States |