Recovery and lifespan of INTERCEPT-treated red blood cells stored 35 days in AS-1
A Randomized, Controlled, Single-Blind, 2-Arm Parallel Study to Assess the Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
This test will see if INTERCEPT-treated autologous red blood cells stored for 35 days survive and circulate as well as untreated AS-1 red blood cells in healthy adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cerus Corporation Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Cincinnati, Ohio and 1 other locations) |
| Trial ID | NCT07015437 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled, single-blind, two-arm phase 2 study in healthy adult donors to compare 24-hour post-infusion recovery and circulating lifespan of 35-day-old autologous RBCs processed with the INTERCEPT Blood System for AS-1 versus untreated AS-1 RBCs. Each subject donates a whole blood unit that is leukoreduced and processed as either the Test (INTERCEPT-treated, processed within 24 or 25–48 hours per randomization) or Control (untreated) component, and an aliquot is aseptically removed on Day 35 for radiolabeling with 51Cr. On Day 35 subjects also provide a fresh blood sample that is radiolabeled with 99mTc for blood volume measurement and the two labeled samples are co-infused to permit simultaneous measurement of recovery and lifespan. Serial blood draws after infusion are used to construct disappearance curves and calculate 24-hour recovery and subsequent survival.
Who should consider this trial
Good fit: Healthy adults aged 18 years or older who meet allogeneic whole blood donation criteria, can consent to autologous blood donation and radiolabeled infusion, and (if of childbearing potential) agree to use contraception are ideal candidates.
Not a fit: Individuals with a history of autoimmune hemolytic anemia, RBC auto- or allo-antibodies, congenital red cell disorders (including reported G6PD deficiency or sickle cell trait), or other exclusionary conditions are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, INTERCEPT-treated RBCs could allow safer blood transfusions by reducing pathogens while preserving red cell survival after storage.
How similar studies have performed: Pathogen-reduction technology is well established for platelets and plasma, and early laboratory and limited clinical data for INTERCEPT-treated RBCs are promising but not yet definitive.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cincinnati, Ohio and 1 other locations
- Hoxworth Blood Center — Cincinnati, Ohio, United States (Not_yet_recruiting)
- American Red Cross Research Laboratory — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Margaret Hennig, Ph.D.
- Email: mhennig@cerus.com
- Phone: 925-288-6178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.