INTERCEPT Blood System for Blood Transfusion Safety

(RedeS Trial)

Not currently recruiting at 15 trial locations

Overseen By Tino LoSicco, Ph.D

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Cerus Corporation

Must not be taking: Chemotherapy, others

Disqualifiers: Pregnancy, Breastfeeding, Massive hemorrhage, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called the INTERCEPT Blood System for Red Blood Cells, designed to make blood transfusions safer by reducing pathogens in red blood cells. It compares the safety and effectiveness of treated blood cells to regular ones. Individuals needing blood transfusions due to conditions like sickle cell anemia or other blood disorders may be suitable candidates. Participants should have received regular blood transfusions for a chronic blood condition such as sickle cell disease. As a Phase 3 trial, this treatment represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking advancement in transfusion safety.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that affect red blood cell viability or bone marrow function, you may not be eligible to participate.

What prior data suggests that the INTERCEPT Blood System for Red Blood Cells is safe for transfusion?

Studies have shown that the INTERCEPT Blood System for Red Blood Cells makes blood transfusions safer by lowering infection risk. This system deactivates various viruses and bacteria in red blood cells. Earlier research found that patients generally tolerated the treatment well, with no serious safety issues reported. The trial's later phase indicates that previous studies have already demonstrated a good safety record. Overall, evidence suggests that the INTERCEPT system is safe for people who need blood transfusions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The INTERCEPT Blood System for Red Blood Cells is unique because it aims to improve the safety of blood transfusions by inactivating a broad range of pathogens, including viruses, bacteria, and parasites, without the need for additional testing. Unlike conventional blood transfusion methods that primarily rely on donor screening and testing to ensure safety, the INTERCEPT system directly treats the blood. Researchers are excited about this approach because it has the potential to significantly reduce the risk of transfusion-transmitted infections, enhancing patient safety and the overall reliability of blood transfusions.

What evidence suggests that the INTERCEPT Blood System for Red Blood Cells is effective for blood transfusion safety?

Research has shown that the INTERCEPT Blood System for Red Blood Cells enhances the safety of blood transfusions by reducing infection risks. This system inactivates a wide range of germs in blood products. Studies have proven its effectiveness in significantly lowering the chance of spreading infections through blood transfusions. In this trial, participants will receive either red blood cell components treated with the INTERCEPT Blood System or conventional red blood cell components as a control. Each year, nearly 2.5 million platelet units undergo treatment with the INTERCEPT system, demonstrating its widespread use and reliability in reducing germs. This treatment aims to improve the safety of red blood cell transfusions, especially in areas with high infection risks. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for people aged 4 and older who need regular blood transfusions due to chronic anemia from conditions like sickle cell, thalassemia, or after chemotherapy. They must not be pregnant, agree to birth control if applicable, and can't have had a recent transfusion or certain allergies.

Inclusion Criteria

I need regular blood transfusions due to a long-term anemia condition.

I am part of a study for sickle cell disease needing regular blood exchanges.

I have been in a regular blood transfusion program for at least 3 months.

Exclusion Criteria

My body is attacking its own red blood cells, causing them to break down.

You have a medical record that shows you have low levels of IgA or have experienced serious allergic reactions to blood products in the past.

- A polyspecific-DAT (any strength) in conjunction with pan-reactivity with a commercial IAT antibody screening panel that precludes the identification of underlying alloantibodies or indicates the presence of autoantibody

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Test or Control RBCs for up to 28 days in the acute transfusion support period

4 weeks

Multiple visits as needed for transfusions

Extension

Optional 6-month extension period for patients requiring repeated transfusion for chronic anemia

6 months

Regular visits for transfusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

75 days

2 visits (in-person) at Day 28 and Day 75

What Are the Treatments Tested in This Trial?

Interventions

• INTERCEPT Blood System for Red Blood Cells

Trial Overview The study tests the INTERCEPT Blood System for treating Red Blood Cells (RBCs) against conventional methods in patients needing RBC support. It aims to see if this system is safe and works well in areas at risk of Zika virus through blood transfusion.

How Is the Trial Designed?

Group I: INTERCEPT (Test) Experimental Treatment 1 Intervention

Red blood cell components treated with the INTERCEPT Blood System for Red Blood Cells ordered and administered to study patients by their treating physicians according to the local standards of care

Group II: Conventional (Control) Active Control 1 Intervention

Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care

INTERCEPT Blood System for Red Blood Cells is already approved in European Union, United States for the following indications:

Approved in European Union as INTERCEPT Blood System for Red Blood Cells for:

• Reduction of transfusion-transmitted infections (TTI) including Zika virus, Dengue, Chikungunya, and TA-GVHD

Approved in United States as INTERCEPT Blood System for Red Blood Cells for:

• Reduction of transfusion-transmitted infections (TTI) including Zika virus, Dengue, Chikungunya, and TA-GVHD

Who Is Running the Clinical Trial?

Cerus Corporation

Lead Sponsor

Trials

20

Recruited

4,800+

Published Research Related to This Trial

The INTERCEPT Blood System™ combined with Platelet Additive Solution PAS-IIIM has been validated for use with both apheresis and pooled buffy-coat platelet components, ensuring compliance with European and French quality standards over a 5-day storage period.

The study confirmed that PAS-IIIM provides superior metabolic and activation profiles for treated platelets compared to the previous PAS-III solution, enhancing the overall effectiveness of the INTERCEPT™ process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro assessment of apheresis and pooled buffy coat platelet components suspended in plasma and SSP+ photochemically treated with amotosalen and UVA for pathogen inactivation (INTERCEPT Blood System™). Chavarin, P., Cognasse, F., Argaud, C., et al.[2014]

A study of 9673 platelet transfusions treated with riboflavin and ultraviolet light showed that while more platelets were needed per patient during the PRT period (7.8 vs. 4.2), the safety improved with fewer febrile and allergic reactions (2.5% vs. 1.2% and 0.16% vs. 0.08%, respectively).

The implementation of pathogen reduction technology (PRT) led to significant cost savings of €284,805.58 due to a drastic reduction in outdated platelets from 16.8% to 0.72%, making it a financially viable option despite the increased platelet usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Our experience in riboflavin and ultraviolet light pathogen reduction technology for platelets: from platelet production to patient care. Jimenez-Marco, T., Garcia-Recio, M., Girona-Llobera, E.[2019]

The INTERCEPT Blood System effectively inactivated a wide range of pathogens in plasma, achieving high log-reduction levels for viruses and bacteria, which suggests it can significantly reduce the risk of transfusion-transmitted diseases.

Despite the pathogen inactivation, the treatment preserved a substantial portion of coagulation factor activity, with retention rates between 72% to 98%, indicating that plasma function remains adequate for transfusion purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photochemical treatment of plasma with amotosalen and long-wavelength ultraviolet light inactivates pathogens while retaining coagulation function. Singh, Y., Sawyer, LS., Pinkoski, LS., et al.[2020]

The study evaluated the safety and efficacy of pathogen-inactivated platelet concentrates (PC) using the INTERCEPT Blood System™ in 51 patients with hematological diseases, finding a low incidence of acute transfusion reactions (1.6%) and no bleeding complications related to the transfusions.

The results indicate that INTERCEPT technology is safe and effective for treating thrombocytopenia, allowing for routine use without the need for additional testing like CMV screening or bacterial testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and clinical efficacy of platelet components prepared with pathogen inactivation in routine use for thrombocytopenic patients. Schlenke, P., Hagenah, W., Irsch, J., et al.[2019]

In a study of 176 patients with acute myeloid leukemia, pathogen-reduced platelets (PR_PLT) showed similar effectiveness to untreated platelets in preventing bleeding when transfused at doses greater than 0.65×10^11/10 kg, allowing for transfusions every 48 hours.

For patients experiencing WHO grade 2 bleeding, PR_PLT transfusions above the same threshold and stored for less than 4 days were more effective in stopping bleeding, highlighting the importance of both quantity and quality in platelet transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of platelet transfusion treated with amotosalen/UVA pathogen inactivation technology (INTERCEPTTM Blood System) in acute myeloid leukemia patients undergoing chemotherapy with curative intent: a single center experience. Ladaique, P., Etienne, JM., Pedini, P., et al.[2023]

The INTERCEPT Blood System, which uses amotosalen and UVA light, effectively inactivates a wide range of pathogens including viruses, bacteria, and protozoa, ensuring enhanced safety in blood transfusions.

With approximately 700,000 INTERCEPT-treated products transfused since its clinical use began in 2002, the system has demonstrated robust safety and efficacy, integrating well into routine blood center operations and showing tolerability in diverse patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathogen Inactivation of Platelet and Plasma Blood Components for Transfusion Using the INTERCEPT Blood System™ Irsch, J., Lin, L.[2022]

The Intercept Blood System (IBS) for platelets significantly enhances the safety of platelet transfusions by reducing the risk of pathogen transmission, including emerging viruses, making it a valuable option for patients requiring transfusions.

Despite high costs associated with its use, the IBS demonstrates comparable cost-effectiveness to other blood safety measures, suggesting it is a worthwhile investment for improving transfusion safety in various medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of transfusion of platelet components prepared with pathogen inactivation treatment in the United States. Bell, CE., Botteman, MF., Gao, X., et al.[2022]

In a study of 50 pooled platelet concentrates, 24% did not meet the INTERCEPT blood system requirements for pathogen inactivation, particularly due to insufficient volumes and excessive red blood cell contamination.

The photochemical treatment process resulted in a significant loss of platelet dose and volume, with 25% of treated units failing to meet the European guideline for platelet dose, highlighting the need for optimization of processing steps before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of processing characteristics of photochemically treated pooled platelets: target requirements for the INTERCEPT Blood System comply with routine use after process optimization. Picker, SM., Speer, R., Gathof, BS.[2023]

Citations

1. 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)

2. 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 ...

3. interceptbloodsystem.com interceptbloodsystem.com/

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

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

Study of INTERCEPT Blood System for Red Blood Cells in ... As part of this treatment use study, additional data will be provided on the safety of INTERCEPT-treated RBCs (IBS RBCs) supplied for routine clinical ...

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

the Red Cell Pathogen Inactivation (ReCePI) study—protocol ... Red blood cell (RBC) transfusion is a critical supportive therapy in cardiovascular surgery (CVS). Donor selection and testing have reduced ...