INTERCEPT Blood System for Red Blood Cells

Recruiting at 1 trial location

Overseen By Margaret Hennig, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cerus Corporation

Must not be taking: Immunosuppressants, RBC viability drugs

Disqualifiers: Autoimmune diseases, Congenital red cell disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 35

Duration: 35 days

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well red blood cells (RBCs) treated with the INTERCEPT Blood System perform after 35 days of storage. It compares the lifespan and performance of these treated RBCs to untreated RBCs stored under the same conditions. After 35 days, participants will receive a small infusion of their own labeled RBCs to observe their behavior in the body. Ideal candidates for this trial have normal blood counts, can donate blood, and do not have specific blood or immune disorders. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in blood storage technology.

Will I have to stop taking my current medications?

The trial requires that you do not take any medication known to affect red blood cell viability, and you must not have had immunosuppressive therapy in the past 28 days. It's best to discuss your current medications with the trial team to see if they are allowed.

What prior data suggests that the INTERCEPT Blood System for RBCs is safe?

Research shows that the INTERCEPT Blood System for Red Blood Cells enhances the safety of blood transfusions by neutralizing harmful germs that cause disease. Previous studies found red blood cells treated with the INTERCEPT system to be safe for use. These studies demonstrated that patients generally tolerated the cells well, with most experiencing no significant side effects. The INTERCEPT system has also been used safely with other blood components, such as platelets and plasma.

The current trial is in an early stage. While initial safety results appear promising, further research is needed for confirmation. However, the system's successful use in other areas suggests a reassuring level of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the INTERCEPT Blood System for Red Blood Cells (RBCs) because it offers a unique way to prepare and store blood. Unlike the standard of care, which relies on conventional blood collection and storage methods, the INTERCEPT system includes a special process that inactivates pathogens in the blood. This means the blood is treated to reduce the risk of transmitting infections to patients. Additionally, this method allows the blood to be stored safely for up to 35 days, potentially improving the safety and availability of blood transfusions.

What evidence suggests that the INTERCEPT Blood System for RBCs is effective for maintaining post-infusion viability?

Research has shown that the INTERCEPT Blood System for Red Blood Cells (RBCs) aims to make blood transfusions safer by eliminating germs in the blood. This system is already used for platelets, with nearly 2.5 million treated each year, demonstrating its ability to reduce infection risks. In this trial, participants will join one of two groups: one where RBCs are prepared with the INTERCEPT Blood System, and another where RBCs follow standard preparation procedures. Early studies on red blood cells have shown that the INTERCEPT system can kill many types of bacteria, which is promising for infection prevention. In other tests, researchers compared treated RBCs to untreated ones to assess their longevity after storage. These results suggest that the INTERCEPT system could enhance the safety and shelf life of stored blood for transfusions. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can participate in a study to evaluate the effectiveness of a blood treatment system called INTERCEPT. The main requirement is that participants must be able to receive an infusion of their own treated red blood cells.

Inclusion Criteria

Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with exceptions for meeting allogeneic deferral criteria due to travel, tattoos/piercings, and male to male sexual contact subject to the Investigator's discretion

Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study

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

Exclusion Criteria

Positive DAT or IAT at study entry

I haven't had a radiolabeled blood component infusion in the last 3 months.

Reenrollment in the same treatment group for which the subject previously contributed recovery and survival data in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an infusion of radiolabeled autologous RBCs and are monitored for recovery and lifespan of RBCs

35 days

Multiple visits for blood sample collection on Day 35, 36, 37, 38, 42, 49, 56, 64, 70

Follow-up

Participants are monitored for adverse events and RBC lifespan post-infusion

90 days

Regular visits for monitoring adverse events and RBC lifespan

What Are the Treatments Tested in This Trial?

Interventions

• INTERCEPT Blood System for RBCs

Trial Overview

The trial tests how well red blood cells (RBCs) treated with the INTERCEPT Blood System survive after being infused back into the participant. It compares these RBCs' survival at 24 hours and overall lifespan against untreated RBCs stored for 35 days.

How Is the Trial Designed?

Group I: Test RBCs will be prepared with the INTERCEPT Blood System for RBCs Experimental Treatment 2 Interventions

One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Test treatment arm for preparation of the Test RBCs. The Test RBCs will be prepared with the INTERCEPT Blood System for RBCs with AS-1, within 24 hours or 25 to 48 hours post collection (depending on randomization assignment) and stored at 1°C to 6°C for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 autologous 51Cr radiolabeled Test RBCs.

Group II: Control RBC components will be prepared according to the site standard operating procedures Experimental Treatment 1 Intervention

One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Control treatment arm for preparation of the Control RBCs in AS-1. The Control RBC components will be prepared and stored at 1°C to 6°C, according to the site standard operating procedures, for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 51Cr autologous radiolabeled Control RBCs.

Who Is Running the Clinical Trial?

Cerus Corporation

Lead Sponsor

Trials

20

Recruited

4,800+

Citations

1.

interceptbloodsystem.com

interceptbloodsystem.com/

INTERCEPT™ Blood System

Nearly 2.5 million platelet units are treated with the INTERCEPT™ Blood System each year. Providing proven broad pathogen inactivation (PI) efficacy backed with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03037164

INTERCEPT Blood System for RBCs Study in Regions at ...

To evaluate the safety and efficacy of red blood cells (RBCs) prepared with the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT)

3.

ir.cerus.com

ir.cerus.com/press-releases/press-releases-details/2025/Cerus-Corporation-Presents-Clinical-Data-for-INTERCEPT-Blood-System-at-the-35th-Regional-International-Society-of-Blood-Transfusion-Congress-in-Milan/default.aspx

Cerus Corporation Presents Clinical Data for INTERCEPT ...

Presentations and abstracts showcase the broad applicability and expected benefits of the INTERCEPT Blood System for platelets, plasma, IFC, and red blood ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10712151/

the Red Cell Pathogen Inactivation (ReCePI) study—protocol ...

The INTERCEPT Blood System for RBCs is in development, and in vitro studies have demonstrated inactivation of a wide range of bacterial species ...

5.

mayo.edu

mayo.edu/research/clinical-trials/cls-20348157

Study of INTERCEPT Blood System for Red Blood Cells in ...

Stage A: To evaluate the safety and efficacy of the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10920064/

Pathogen reduced red blood cells as an alternative to ...

Pathogen inactivation technology was developed primarily to increase safety by preventing transmission of infectious diseases. The Intercept Blood System for ...