Measurement of the Recovery and Lifespan of Red Blood Cells From Pathogen-Reduced, Stored Blood Units Using Cellular Biotinylation
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 24 hour post-infusion recovery of autologous RBC stored in AS-5 for 35 days and then labeled with either 51Cr or biotin.
研究概览
简要总结
The pilot study has two objectives: 1) to assess the post-infusion viability of INTERCEPT RBC by measuring the 24 hour post-infusion recovery ("PTR24") and lifespan of autologous RBCs prepared with the INTERCEPT System for RBC after storage for 35 days under standard blood banking conditions using two different RBC labels; 51-chromium and biotin. The control will be conventional untreated RBCs stored for 35 days; and 2) comparison and contrast of PTR24 and lifespan results of the 51-chromium and biotin labeling methods of RBC stored for 35 days under standard blood banking conditions. The purpose of gathering these data is to obtain more meaningful survival data for stored conventional and INTERCEPT RBCs over the entire 120 d RBC lifespan (51-Cr labeled RBC permits a maximum 28 d assessment as a result of 51-Cr's variable, progressive elution from RBC and radioactive half-life).
详细描述
Each subject will receive one infusion of autologous, radiolabeled and BioRBC labeled INTERCEPT RBCs (Test RBCs) and one infusion of autologous BioRBC labeled untreated RBCs (Control RBCs) concomitantly. Each infusion will be approximately 20 mL, i.e., 10 mL of 51-chromium labeled RBC, and 10 mL of either BioRBC-6 or BioRBC-18 which will be stratified as indicated above based on the Test or Control designation.
Treatment Compliance Healthy subjects who understand the study commitments and sign the informed consent will be enrolled in the study. Treatment compliance and follow-up testing will be tracked by the Investigator, recorded on the case report form (CRF), and monitored by the Sponsor.
ASSESSMENT OF EFFICACY
Efficacy Parameters
Efficacy endpoints include the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Subject Inclusion Criteria
- •Up to 12 subjects will be enrolled for a maximum of 6 eligible subjects in the pilot study to provide preliminary RBC survival data to support a subsequent adequately powered study capable of addressing the two objectives as stated above.
- •Age ≥18 years, of either gender
- •Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- •Weight over 140 lbs.
- •Complete blood count (CBC; including RBC indices MCV, MCH, MCHC, and RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, LDH, ALT, AST,total bilirubin, BUN, creatinine). Values outside of normal reference range if considered not to be clinically significant may be allowed with a protocol exception.
- •Minimum hemoglobin levels of 13 g/dL for female and 14 g/dL for male subjects
- •Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, WNV and Zika virus
- •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 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 alloantibodies or autoimmune disease
- •History of congenital red cell disorders including glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Positive Direct (DAT) and Indirect antiglobulin test (IAT)at study entry
- •Immunosuppressive therapy (e.g., oral or 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 INTERCEPT treated or BioRBCs
- •Pre-existing antibody specific to INTERCEPT RBCs or BioRBC
- •Subjects are excluded if receiving immunosuppressive therapies (e.g., oral or intravenous corticosteroids) due to their potential to obscure immunogenicity or immunoreactivity to Test RBCs.
- •Subjects donating blood for any other purpose
- •Subjects who have received blood transfusion within the previous year
- •Subjects who are enrolled in another study.
研究组 & 干预措施
Open label
Red cell recovery/survival analysis of untreated and INTERCEPT treated RBC concomitantly
干预措施: Red cell survival in INTERCEPT treated red cells (Device)
结局指标
主要结局
24 hour post-infusion recovery of autologous RBC stored in AS-5 for 35 days and then labeled with either 51Cr or biotin.
时间窗: 24 hours
次要结局
- Mean lifespan of autologous RBC stored for 35 days and then labeled with either 51Cr or biotin(days 37, 38, 42, 49, 56, 63, 77, 91, 105, 119, 133 and 147)
- Median lifespan (T50) of autologous RBC stored for 35 days and then labeled with either 51Cr or biotin(days 37, 38, 42, 49, 56, 63, 77, 91, 105, 119, 133 and 147)
- Area under the curve (AUC) determined using data points collected for RBC lifespan of autologous, radiolabeled or BioRBCs(days 37, 38, 42, 49, 56, 63, 77, 91, 105, 119, 133 and 147)
研究者
Jose Cancelas
Professor, Research Division Director, Hoxworth Blood Center
University of Cincinnati