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Clinical Trials in the USA / NCT07015437
Recruiting Phase 2

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

NCT07015437 · tracked via the Priya Life Science USA tracker
Sponsor
Cerus Corporation
Phase
Phase 2
Started
2025-09-19
Last updated
2025-10-15

Condition(s) studied

Healthy Subjects

Investigational drug(s) / intervention(s)

INTERCEPT Blood System for RBCsInfusion of autologous radiolabeled RBCs

INTERCEPT Blood System for RBCs: RBCs treated with the INTERCEPT Blood System for RBCs

Infusion of autologous radiolabeled RBCs: Subject will receive a single intravenous infusion of approximately 10 to 30 mL of autologous Day 35 51Cr radiolabeled RBCs and fresh 99mTc RBCs.

Study summary

The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Hoxworth Blood Center Cincinnati Ohio Not Yet Recruiting
American Red Cross Research Laboratory Norfolk Virginia Recruiting

More Cerus Corporation trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07015437 on ClinicalTrials.gov ↗ ← All trials in the USA