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 | 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 |
| 2 | NCT03593902 (ClinicalTrials.gov) | May 17, 2018 | 28/6/2018 | Cardiac Safe Transplants for Systemic Sclerosis | Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction | Systemic Sclerosis;Scleroderma | Drug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Terminated | 18 Years | 65 Years | All | 9 | Phase 2/Phase 3 | United States |
| 3 | 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 |
| 4 | NCT01445821 (ClinicalTrials.gov) | September 15, 2011 | 29/9/2011 | Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial | Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb) | Scleroderma, Systemic | Biological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: Fludarabine | Northwestern University | NULL | Terminated | 17 Years | 60 Years | All | 44 | Phase 3 | United States |
| 5 | 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 | |||
| 6 | JPRN-UMIN000000589 | 2007/02/01 | 14/02/2007 | Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis | systemic sclerosis (SSc) | Granulocyte-colony stimulating factor (G-CSF), "Gran" | Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine | NULL | Complete: follow-up complete | 18years-old | 70years-old | Male and Female | 8 | Phase 1,2 | Japan | |
| 7 | 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 |