Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
Start Date
4/1/2026
Completion Date
12/31/2027
Summary
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biotinylated Red Blood Cells (BioRBC)
Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)
51 Chromium Labeled Red Blood Cells (51Cr RBC)
Technetium 99m Labeled Red Blood Cells (99mTc RBC)
Conditions
Locations
Hoxworth Blood Center, University of Cincinnati
Cincinnati, Ohio 45267
United States
American Red Cross
Norfolk, Virginia 23510
United States