A Randomized, Controlled, Single-Blind, 2-Period Crossover Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs)
研究概览
简要总结
The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to conventional untreated RBCs stored for 35 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at least 18 years, of either gender
- •Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- •Complete blood count (CBC); including red blood cell (RBC) indices mean cell volume (MCV), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and RBC distribution width(RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea nitrogen (BUN), creatinine). Values outside of normal reference range thought not to be clinically significant may be allowed with a protocol exception.
- •Minimum hemoglobin levels of 13 g/dL for female and 14.5 g/dL for male subjects
- •Negative blood donor screening test panel for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), human T cell leukemic virus (HTLV), Syphilis, and west nile virus (WNV) (if available)
- •Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
- •Meet or exceed American Association of Blood Banks (AABB) guidelines for blood donation (with the exception of travel deferrals).
- •Signed and dated informed consent form
排除标准
- •• Clinically significant acute or chronic disease (as determined by the Investigator)
- •History of RBC autoantibodies/autoimmune hemolytic anemia, RBC allo-antibodies, or autoimmune disease
- •History of congenital red cell disorders including glucose 6 phosphate dehydrogenase (G-6PD) deficiency
- •Serum ferritin <12 ng/mL
- •Positive direct antiglobulin test (DAT) or indirect antiglobulin test (IAT) at study entry
- •Immunosuppressive therapy (e.g., oral or Intravenous (IV) prednisone) within the past 28 days
- •Treatment with any medication known to affect RBC viability
- •Pregnant or nursing female
- •Male subjects or female subjects of childbearing potential not using effective contraception
- •Participation in another clinical study currently or within the past 28 days
- •Prior exposure to S 303 treated RBCs
- •Pre-existing antibody specific to S 303 treated RBCs
研究组 & 干预措施
S303 Red Blood Cells (RBCs)
Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs).
干预措施: S303 Red Blood Cells (RBCs) (Biological)
S303 Red Blood Cells (RBCs)
Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs).
干预措施: Conventional, untreated Red Blood Cells (RBCs) (Biological)
Conventional, Untreated Red Blood Cells (RBCs)
Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs).
干预措施: S303 Red Blood Cells (RBCs) (Biological)
Conventional, Untreated Red Blood Cells (RBCs)
Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs).
干预措施: Conventional, untreated Red Blood Cells (RBCs) (Biological)
结局指标
主要结局
Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs)
时间窗: 70 days
Incidence of antibody specific to S 303 treated RBCs
Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days
时间窗: 70 Days
24 hour post-infusion recovery of autologous RBCs stored for 35 days (assessed using the Food and Drug Administration (FDA)) criteria for evaluation of in vivo RBC studies)
次要结局
- Secondary Safety: Incidence of adverse events(70 Days)
- Secondary Efficacy Endpoint:(70 days)
- Secondary Efficacy Endpoint(70 days)