Evaluation of the Safety of Repeated Autologous Infusions of Enzyme-Converted A-to-O (A-ECO) Red Cells Into Group A Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Adverse events, clinically significant bruising over a period of 10 weeks.
研究概览
简要总结
The purpose of this study is to demonstrate that small amounts of a person's own red cells, when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused, repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and re-infused five times. Additional samples of blood will be drawn for testing and evaluation.
详细描述
This study will involve a statistically valid number of subjects so that firm conclusions may be drawn about the safety of small volumes of A-ECO cells. All participants will receive their own (autologous) red cells that have been either: 1) treated with an enzyme to create A-ECO cells (test group); or 2) washed with saline (control group). The test and control groups will be compared for the rate and extent any adverse reactions or unexpected laboratory test results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer subjects who have no clinically apparent cardiovascular, renal, pulmonary, endocrinological, autoimmune or neurological disorders
- •Blood Group A
- •Available for follow up periodically at varying intervals for twelve weeks
- •Have a clinical presumption of a stable blood volume
- •Between 18 and 65 years of age
- •Able to provide informed consent
- •Practicing contraception, other than oral or systemically delivered contraceptives, while participating in the study (subjects of potential reproductive age).
排除标准
- •Women that are pregnant
- •Persons with documented immune deficiencies
- •Persons found to have abnormal platelet function or anti-platelet antibodies as determined by a pre-study screen
- •Persons with a history of idiopathic thrombocytopenic purpura
- •Persons who are bleeding or undergoing an active hemolytic process
- •Persons who have any history of hemorrhagic tendency
- •Persons who are taking any drug known to interfere with hemostasis, or who take combinations of drugs that have been reported to cause hemostatic problems or interfere with laboratory coagulation and platelet function testing
- •Persons who test positive for von Willebrand's disease
- •Persons taking investigational drugs or using an investigational device
- •Persons with a family history of a bleeding disorder
- •Persons with a history of vasculitis
- •Persons with a history of a dermatological disorder that might be confused with bruising in the judgement of the investigator
- •Persons with medical conditions which represent a contraindication to any study procedure, in the judgement of the investigator
- •Persons with unexplained bruising
- •Persons with abnormal laboratory screening tests
结局指标
主要结局
Adverse events, clinically significant bruising over a period of 10 weeks.
次要结局
- Unexpected lab test results over 10 weeks.