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New blood treatment aims to make transfusions safer

NCT ID NCT07015437

Knowledge-focused Sponsor: Cerus Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This study tests a device called the INTERCEPT Blood System that treats red blood cells to kill germs. Researchers want to see if treated red blood cells survive as well as untreated ones after 35 days of storage. About 70 healthy adults will donate blood, have it treated or not, and then get a small amount back to measure how long the cells last. The goal is to ensure the treated blood is safe and effective for future transfusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INTERCEPT Blood System for RBCs (device) and radiolabeled autologous red blood cells
What this could lead to
If successful, this could show that INTERCEPT-treated red blood cells are safe and viable for transfusion, potentially reducing infection risks in blood transfusions.
What could go wrong
This is an early phase 2 study in healthy volunteers, not patients. The treatment may not perform as well as standard RBCs, and results may not translate to real-world transfusion settings.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

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

Started

Sep 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Age ≥18 years * Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant. * Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with the following exceptions: * Meeting allogeneic deferral criteria due to travel, tattoos/piercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion. * Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study. * Signed and dated informed consent form Exclusion Criteria: * History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease * History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait) * Positive DAT or IAT at study entry * Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days * Treatment with any medication known to affect RBC viability * Pregnant or nursing females * Participation in another interventional clinical study currently or has received an investigational drug within the past 28 days * Less than three months from receiving an infusion of a radiolabeled blood component. * Reenrollment in the same treatment group for which the subject previously contributed recovery and survival data in this study. * Non study blood component donation throughout the study * Preexisting antibody specific to INTERCEPT RBCs * History of known hypersensitivity to chromium or technetium

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy subjects

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

    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

  • American Red Cross Research Laboratory

    RECRUITING

    Norfolk, Virginia, 23510, United States

  • Hoxworth Blood Center

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45267, United States

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