Standard of Care Trial: Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. This study also monitors the activity and toxicity of total body irradiation and cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.
详细描述
This protocol identifies a standard-of-care method for unrelated stem cell transplantation in adults. Performing this service in a consistent and documented fashion allows investigators to obtain informed consent from recipients. Data is tabulated locally for quality-control comparisons with nationally-reported standards. As a condition of maintaining transplant center status and to have acess to NMDP-registered donors, UCSF submits clinical and outcome data to the NMDP. As a result, UCSF is contributing to the resolution of remaining uncertainties regarding particular transplantation practices.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 54 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >15 and <55
- •Adequate renal function with serum creatinine <2.0 mg/dl
- •Pulmonary diffusing capacity>50% of predicted
- •Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
- •Total bilirubin must be <2.5 mg/dl.
- •Alkaline phosphatase and AST must be less than three times the upper limit of normal
- •Negative serology for the human immunodeficiency virus
- •Available HLA-matched donor
- •Signed informed consent
排除标准
- •No fully or single-antigen-mismatched sibling donor is available to donate stem cells
- •No active liver disease.