Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
Purpose
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.
Condition
- Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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). |
|
|
Experimental 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). |
|
Recruiting Locations
Cincinnati, Ohio 45267
More Details
- Status
- Recruiting
- Sponsor
- Jose Cancelas
Detailed Description
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.