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Comparing Red Blood Cell Labeling Methods in Healthy Volunteers

This study is comparing two ways to label red blood cells (RBCs) to see how long they survive in your body after a transfusion. Researchers are testing Biotinylated Red Blood Cells (BioRBC) and Irradiated Biotinylated Red Blood Cells against the standard 51 Chromium Labeled Red Blood Cells (51Cr RBC). The goal is to see if BioRBC can be used instead of 51Cr RBC, which is radioactive. You can join if you are a healthy adult, at least 18 years old, and meet certain height and weight requirements. The study will be successful if BioRBC shows similar recovery and survival rates as 51Cr RBC. The current status of this study is unclear, and about 20 people are expected to participate.

Study design
This is a randomized, controlled study in healthy adult volunteers, comparing different red blood cell labeling methods. About 20 people are expected to participate.
What's involved
Study procedures include screening, blood samples, testing, labeling, and a transfusion.
Compensation
Not stated in the trial record.
Follow-up
You will be followed from immediately after the infusion through Day 112 post-infusion (about 16 weeks after the transfusion).

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NCT07446647

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

Recruiting
PHASE1Ages 18+Interventional
Jose Cancelas
~20 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested: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)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Measured over Day 1 after completion of autologous RBC infusion (Day 43 of the study)
+1 more outcome measured

Conditions

Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused

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Healthy Volunteer

Where it's being run

2 sites across 2 states
Ohio1
Virginia1

Study leadership

  • Jose A Cancelas-Perez, MD, PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Jose A Cancelas-Perez, MD, PhD
[email protected]
617-632-3446
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood CellsDay 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 CellsFrom 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