Scientists test Vitamin-Based tracking to replace radioactive dyes in blood studies
NCT ID NCT07446647
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two methods for tracking red blood cells after transfusion: the standard radioactive chromium method and a newer method using biotin (a vitamin). Twenty healthy volunteers will receive their own blood cells labeled with both methods to see if the biotin method works just as well without radiation. The goal is to find a safer, non-radioactive alternative for future blood product studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Biotinylated red blood cells, irradiated biotinylated red blood cells, 51-chromium labeled red blood cells, technetium-99m labeled red blood cells
- What this could lead to
- If successful, this could provide a non-radioactive method to track red blood cells in future studies, improving safety for participants.
- What could go wrong
- This is a small, early-phase study in healthy volunteers, not patients. The biotin method may not prove as reliable as the current standard, limiting its adoption.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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American Red Cross
NOT_YET_RECRUITINGNorfolk, Virginia, 23510, United States
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Hoxworth Blood Center, University of Cincinnati
RECRUITINGCincinnati, Ohio, 45267, United States