SCLERODERMA CYCLOPHOSPHAMIDE OR TRANSPLANTION STUDY (SCOT)

硬皮病环磷酰胺或移植研究 (SCOT)

• 批准号: 9004255
• 负责人: KEITH SULLIVAN
• 金额: $ 76.6万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-11-01 至 2015-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9004255
• 关键词: Antithymoglobulin; Autologous; Autologous Transplantation; Blood; CD34 gene; Clinical Trials; Contractor; Cyclophosphamide; Data; Disease-Free Survival; Dose; Enrollment; Intravenous; Multicenter Studies; Phase; Physiologic pulse; Protocols documentation; Randomized; Scleroderma; Stem cell transplant; Systemic Scleroderma; Testing; Therapeutic immunosuppression; Transplantation; Whole-Body Irradiation; open label

The contractor shall complete the clinical trial entitled �Protocol #: SCSSc-01 A Randomized, Open-Label, Phase II/III Multi-Center Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis� hereafter referred to as the �SCOT (Scleroderma: Cyclophosphamide or Transplantation) Trial.�

承包商应完成题为“方案编号：SCSSc-01 使用全身照射、环磷酰胺、ATGAM 和自体移植进行高剂量免疫抑制治疗的随机、开放标签、II/III 期多中心研究”的临床试验。 -CD34+HPC与静脉脉冲环磷酰胺治疗严重系统性硬化症（下文简称）作为 SCOT（硬皮病：环磷酰胺或移植）试验。