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

Launched by CERUS CORPORATION · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to prepare red blood cells (RBCs) using a method called the INTERCEPT Blood System. The main goal is to see how well these specially prepared RBCs work after being infused into healthy volunteers, specifically looking at how many RBCs are still functioning 24 hours later and how long they last in the body. The trial will compare these INTERCEPT RBCs with standard RBCs that are not treated, both of which will have been stored for 35 days before the infusion.

To be part of this study, participants need to be at least 18 years old and generally healthy, with normal blood test results. They must also agree to use contraception if they can become pregnant. However, people with certain medical histories, such as autoimmune diseases or specific red blood cell disorders, cannot participate. This study has not started recruiting participants yet, but those who take part can expect to provide blood samples and undergo monitoring, helping researchers learn more about the safety and effectiveness of this new RBC preparation method.

Gender

ALL

Eligibility criteria

• 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