Scientists test Vitamin-Based tracking to replace radioactive dyes in blood studies

NCT ID NCT07446647

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • American Red Cross

    NOT_YET_RECRUITING

    Norfolk, Virginia, 23510, United States

  • Hoxworth Blood Center, University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States