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Recovery and Lifespan Study for INTERCEPT Red Blood Cells

This study is looking at how well red blood cells (RBCs) treated with the INTERCEPT Blood System for RBCs work in the body. Researchers want to see if these treated RBCs, stored for 35 days, stay in circulation as long as untreated RBCs. You would receive a small amount of your own radiolabeled RBCs (RBCs with a tiny, safe amount of radioactive material to track them) through an IV. The main goal is to measure the percentage of these cells still in your bloodstream 24 hours after infusion. This study is for healthy adults aged 18 and older. The current recruitment status is unclear.

Study design
This is a randomized, controlled, single-blind study with two groups, involving 70 healthy participants. You would be assigned to either receive INTERCEPT-treated or untreated red blood cells.
What's involved
You will donate whole blood, which will be processed into red blood cells. On Day 35, you will return to the site to receive an intravenous infusion of your own radiolabeled red blood cells.
Compensation
Not stated in the trial record.
Follow-up
Your red blood cell levels will be measured at several time points up to 24 hours after the infusion.

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NCT07015437

A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1

Recruiting
PHASE2Ages 18+Interventional
Cerus Corporation
~70 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:INTERCEPT Blood System for RBCsInfusion of autologous radiolabeled RBCs

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion
Measured over Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion

Conditions

Healthy Subjects

Explore related trials

Healthy

Where it's being run

2 sites across 2 states
Ohio1
Virginia1

Who to contact

Margaret Hennig, Ph.D.
[email protected]
925-288-6178
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusionPre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion

    The 24-hour recovery will be calculated using the subject's blood volume derived from infusion of 99mTc-labeled fresh RBCs.