NCT01277549已完成不适用
Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors
Terumo BCT3 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 3
- 主要终点
- Mononuclear Cell Collection Efficiency
研究概览
简要总结
The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of differentiation 34 (CD34) positive cells from healthy nonmobilized blood donors and healthy G-CSF (granulocyte colony stimulating factor) mobilized blood donors, respectively.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acceptable health history to allow blood product collection
- •Weight >50<125 Kg (kilogram).
- •Male or non-pregnant, non-nursing female.
- •General good health, as determined by questionnaire.
- •Normal prescreening complete blood count.
- •Platelet count>150 x 10^3/uL (microliter) at initial screening and >120 x 10^3/uL immediately prior to leukapheresis.
- •Adequate peripheral venous access to allow collection of product.
- •Able to read, understand, and sign the informed consent form. Additional Inclusion Criteria for Mobilized Subjects
- •If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection.
- •If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection.
排除标准
- •a) Collection or loss of:
- •more than a ½ pint (1 cup) of whole blood within the prior 56 days or,
- •more than 3 L (liter) of whole blood or 1.5 L of red blood cells within the prior 12 months or,
- •more than 12 L of plasma within the prior 12 months or,
- •a leukapheresis within the prior six weeks or,
- •a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months or,
- •a plasmapheresis within the prior 48 hours or two within the prior 7 days.
- •Acute or symptomatic chronic lung disease.
- •Active or chronic heart disease, including hypertension controlled by medication.
- •History of hematologic malignancy or chronic hematologic disorder or bleeding disorder.
- •Reactive test indicative of infection with T. pallidum, Human T-lymphotropic virus, HIV, Hepatitis C Virus, or Hepatitis B Virus (except isolated Hepatitis B Core Antibody Reactivity.
- •Presence of psychological traits or physiological or medical conditions that would make subject unlikely to tolerate the procedures.
- •Subjects taking prescription medications other than those deemed allowable by the investigator.
- •Abnormal serum electrolytes or serum calcium levels.
- •Abnormal serum creatinine level.
- •Abnormal liver function results on ALT (alanine amino transferase) test.
- •Abnormal coagulation testing on prothrombin time or partial thromboplastin time.
- •Inadequate antecubital veins for leukapheresis or inability or unwillingness to tolerate leukapheresis.
- •If female, pregnant or lactating. Additional Exclusion Criteria for Mobilized Subjects
- •Received a G-CSF injection in the prior 4 months, or received more than twenty-five (25) doses of G-CSF (a dose includes several individual injections administered on one occasion).
- •Known hypersensitivity to G-CSF or any E. coli-derived products.
- •History of autoimmune condition or disorder, unless approved by principal investigator.
- •Immediate family history (parents, grandparents, siblings, children) of hematologic malignancy.
- •Active or history of iritis (anterior uveitis) or episcleritis.
- •History of deep vein thrombosis or pulmonary embolism.
- •Current treatment with lithium.
- •Spleen tip palpable during physical exam.
- •Positive SickleDex test.
结局指标
主要结局
Mononuclear Cell Collection Efficiency
时间窗: One day
The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.
CD34+ Cell Collection Efficiency
时间窗: one day
The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.
次要结局
- Platelet Collection Efficiency(One Day)
- Hematocrit of MNC Product(One Day)
- Granulocyte % of MNC Product(One day)
- Viability of the Collected MNC Product(One day)
研究者
研究点 (3)
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