NL-OMON37006撤回不适用
Intra-marrow transplantation of Mesenchymal Stromal Cells to treat MyeloDysplastic Syndromes: A feasibility study - PMDS28 / Intra-marrow transplantation of Mesenchymal Stromal Cells in MDS
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 29 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Subjects with a cytopathologically confirmed diagnosis of
- •(a) Patients with MDS RCUD, MDS RARS, MDS RCMD, MDS RAEB-1 and an IPSS * 1 (appendix C)
- •(b) An indication for treatment: patients should have had at least one red blood cell (RBC) transfusion in the two months prior to inclusion due to a hemoglobin level < 6 mmol/l,
- •Note: Subjects with thrombocytopenia or neutropenia are eligible.
- •* MDS RCUD, MDS RARS, MDS RCMD, MDS RAEB-1 and an IPSS * 1 and erythropoietin level <500 iU/l and progressive after first line erythropoietin treatment.
- •* MDS RCUD, MDS RARS, MDS RCMD, MDS RAEB-1 and an IPSS * 1 and 5q- cytogenetic abnormality and progressive after first line lenalidomide treatment.
- •* WHO performance status of 0, 1 or 2 (see appendix F)
- •* Written informed consent
排除标准
- •* MDS RCUD, MDS RARS, MDS RCMD, MDS RAEB-1 and an IPSS * 1 and erythropoietin level <500 iU/l and not having received erythropoietin treatment
- •* MDS RCUD, MDS RARS, MDS RCMD, MDS RAEB-1 and an IPSS * 1 and 5q- cytogenetic abnormality and not having received lenalidomide treatment
- •* MDS RCUD, MDS RARS, MDS RCMD, MDS RAEB-1 and an IPSS * 1 who have been treated with immune suppressive drugs (e.g. corticosteroids, calcineurin inhibitors) during the last 6 months
- •* Impaired hepatic or renal function as defined by:
- •* ALT and/or AST > 2.5 x normal value
- •* Bilirubin > 2 x normal value
- •* Serum creatinin > 2 x normal value (after adequate hydration)
- •* Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
- •* Cardiac dysfunction as defined by:
- •* Myocardial infarction within the last 6 months of study entry, or
- •* Reduced left ventricular function with an ejection fraction <50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
- •* Unstable angina
- •* Unstable cardiac arrhythmias
研究者
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