EUCTR2008-000040-13-AT进行中（未招募）1 期
Effects of recombinant human Erythropoietin on circulating and intramuscular endothelial progenitor cells, neovascularisation and oxidative metabolism of skeletal muscle in Friedreich’s Ataxia
Medizinische Universität Innsbruck, Univ.-Klinik für Neurologie0 个研究点目标入组 7 人开始时间: 2009年1月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Seven adult subjects with definite FRDA will be enroled in this study. Skeletal muscle will be ob-tained by an open biopsy from at baseline (untreated) and after 2 months of rhuEPO treatment after written informed consent. Treatment encompasses rhuEPO 3.000 IU (~100 IU/kg KG) three times weekly subcutaneously for 8 weeks. Specimen from the quadriceps muscle and MR spec-troscopy from the contralateral side will be obtained pre- and post rhuEPO treatment. Frataxin-levels will be assessed in lymphocytes and muscle specimen at baseline and study end-point. Fur-thermore, FACS analysis of circulating CD34+ and CD133+ cells in peripheral blood will be perfo-med bi-weekly. The numbers of CD34+ and CD133+ cells and capillary density per mm2 will be quantified in skeletal muscle at baseline and after 8 weeks EPO treatment. Biochemically, complex I, II, and III of the respiratory chain in the quadriceps muscle will be evaluated pre-and post treat-ment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for participation in this study are hemoglobin-levels above 14mg/dl at the begin-ning of the study, malignancies, thrombocytosis, other diseases like chronic inflammatory disease, chronic alcohol abuse, severe diabetes mellitus type I and II (HbA1c above 8%), chronic liver in-sufficiency, epilepsy, cardiac insufficiency (NYHA above 2), history of thrombotic / thromboembolic events, anticoagulation, pregnancy and breast feeding, iron deficiency, vitamin B12 and folate de-ficiency, cardiovascular diseases, severe psychiatric disorders, known hypersensitivity to erythro-poietin, participation to another clinical trial.
研究者
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