Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
研究概览
简要总结
This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red blood cell (RBC) labeling method and the Biotin (BioRBC) red blood cell (RBC) labeling method to determine if biotinylated red blood cells (BioRBC) is an acceptable non radioactive alternative to 51 chromium (51Cr) radiolabeling for regulatory pharmacokinetic studies of red blood cell products.
详细描述
This is a Phase 1, randomized, controlled, autologous transfusion study in healthy adult volunteers designed to compare biotinylated red blood cells (BioRBC) with 51 chromium (51Cr)-labeled red blood cells for the assessment of red blood cell (RBC) recovery and survival after 42 days of storage, with and without irradiation at Day 0.
Both 51Cr and biotin labeling have been used to measure autologous RBC recovery and survival, but biotin has not yet been accepted by the U.S. Food and Drug Administration (FDA) as a method to determine 24 hour post transfusion recovery and long term survival after storage.
Study procedures include screening, blood samples, testing, labeling and transfusion.
It is expected that about 20 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Signed and dated informed consent form.
- •Age ≥18 years, of either gender.
- •Normal health status (as determined by Investigators' review of medical history and physical exam).
- •Qualifies for a collection; Males: height >5'1" and weight >130 lbs; Females: height >5' 5" and weight > 150 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, and ferritin). Values outside of normal reference range if considered not to be clinically significant by the site PI may be allowed as per the site PI.
- •Hemoglobin levels >13.3 g/dL and hematocrit >40% for both male and female subjects.
- •Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, and WNV virus at the time of donation.
- •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 as defined by site-specific SOPs.
排除标准
- •Known RBC disorder that could affect RBC survival.
- •Treatment with any medication known to affect RBC viability.
- •Pregnant or nursing female.
- •Male subjects or female subjects of childbearing potential not using medically acceptable contraceptive methods.
- •Participation in another clinical study currently or within the past 28 days.
- •Subjects not eligible to provide a double RBC donation per AABB guidelines for blood donation.
- •Subjects who have received blood transfusion within the previous year.
- •Known pre-existing antibody specific to BioRBC.
- •Subjects who have received a previous infusion of BioRBC at any time.
研究组 & 干预措施
Unirradiated Red Blood Cells
Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized.
Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs).
干预措施: Biotinylated Red Blood Cells (BioRBC) (Biological)
Unirradiated Red Blood Cells
Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized.
Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs).
干预措施: 51 Chromium Labeled Red Blood Cells (51Cr RBC) (Biological)
Unirradiated Red Blood Cells
Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized.
Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs).
干预措施: Technetium 99m Labeled Red Blood Cells (99mTc RBC) (Biological)
Gamma Irradiated Red Blood Cells
Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized.
Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs).
干预措施: Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC) (Biological)
Gamma Irradiated Red Blood Cells
Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized.
Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs).
干预措施: 51 Chromium Labeled Red Blood Cells (51Cr RBC) (Biological)
Gamma Irradiated Red Blood Cells
Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized.
Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs).
干预措施: Technetium 99m Labeled Red Blood Cells (99mTc RBC) (Biological)
结局指标
主要结局
24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
时间窗: Day 1 after completion of autologous RBC infusion (Day 43 of the study)
Percentage of infused autologous red blood cells (RBC) remaining in circulation 24 hours after transfusion
Lifespan of of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
时间窗: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).
Survival of autologous irradiated RBC expressed as days of RBC present in blood until they disappear from circulation
次要结局
- T50 of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells(From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).)
- Area under the curve (AUC) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells(From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).)
- Incidence of Adverse Events and Serious Adverse Events Following Infusion of Biotinylated and Irradiated Biotinylated Red Blood Cells(From Day 42 (infusion day) through Day 154 (approximately 16 weeks post transfusion))
- Incidence of Antibodies Against Biotinylated Red Blood Cells After Infusion of BioRBC(From screening (up to 28 days before donation) through Day 112 post infusion (day 154 after red blood cell collection); extended follow up annually if anti BioRBC is detected until it disappears from circulation.)
研究者
Jose Cancelas
Sponsor-Investigator
Dana-Farber Cancer Institute