Back to Trials
NCT07446647PHASE1RecruitingAccepts Healthy Volunteers

Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion

Jose Cancelas

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

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.

Interventions

BIOLOGICAL

Biotinylated Red Blood Cells (BioRBC)

BIOLOGICAL

Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)

BIOLOGICAL

51 Chromium Labeled Red Blood Cells (51Cr RBC)

BIOLOGICAL

Technetium 99m Labeled Red Blood Cells (99mTc RBC)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused

Locations

Hoxworth Blood Center, University of Cincinnati

Cincinnati, Ohio 45267

United States

American Red Cross

Norfolk, Virginia 23510

United States