Actively Recruiting
A Randomized, Controlled, Single-Blind Study to Assess Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Red Blood Cells With AS-1
Led by Cerus Corporation · Updated on 2025-10-15
70
Participants Needed
2
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the recovery and lifespan of autologous red blood cells (RBCs) treated with the INTERCEPT Blood System for RBCs with AS-1 in healthy adult subjects. This Phase 2, randomized, controlled, single-blind study compares 35-day-old INTERCEPT-treated RBCs to untreated RBCs stored for the same period. The objective is to measure the 24-hour post-infusion recovery and the lifespan of these RBCs to assess their viability after storage and treatment. Participants will donate a unit of whole blood that is processed to produce RBC components treated either with the INTERCEPT Blood System (Test group) or untreated as per standard procedures (Control group). These RBCs are stored at 1°C to 6°C for 35 days. On Day 35, subjects receive a single intravenous infusion of approximately 10 to 30 mL of their own radiolabeled RBCs. The study involves infusions of 51Cr-labeled RBCs from treated or untreated blood, alongside 99mTc-labeled fresh RBCs, to measure recovery and blood volume. Participants will provide multiple blood samples at various times after infusion to measure RBC recovery, volume, and lifespan up to 35 days post-infusion. Safety is monitored for 24 hours after blood donation and infusion, focusing on adverse events and transfusion reactions. Additional laboratory testing of RBC samples at different stages will evaluate in vitro RBC properties. The total study duration and detailed monitoring ensure comprehensive evaluation of RBC viability and safety.
CONDITIONS
Brief Title
A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Complete blood count (CBC) and serum chemistry values within normal limits or clinically insignificant deviations
- Meet FDA, AABB, or institutional guidelines for allogeneic whole blood donation, including viral marker testing
- Acceptable deferral exceptions for travel, tattoos/piercings, and male-to-male sexual contact at investigator discretion
- Agreement to use medically acceptable contraception if of childbearing potential
- Signed and dated informed consent form
You will not qualify if you...
- History of red blood cell autoantibodies, autoimmune hemolytic anemia, allo-antibodies, or other autoimmune diseases
- History of congenital red cell disorders including G-6PD deficiency, sickle cell trait, or thalassemia minor trait
- Positive direct or indirect antiglobulin test at study entry
- Use of immunosuppressive therapy within past 28 days
- Treatment with medications affecting red blood cell viability
- Pregnant or nursing females
- Participation in another interventional clinical study or investigational drug use within past 28 days
- Less than three months since receiving infusion of radiolabeled blood component
- Previous enrollment in the same treatment group with recovery and survival data
- Donation of non-study blood components during the study
- Preexisting antibody specific to INTERCEPT RBCs
- Known hypersensitivity to chromium or technetium compounds
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 35 days
Participants donate one unit of whole blood which is processed to prepare red blood cells either treated with the INTERCEPT Blood System or untreated, depending on randomization.
1 visit for blood donation
Duration - 1 day
Participants receive a single intravenous infusion of approximately 10 to 30 mL of autologous radiolabeled red blood cells prepared on Day 35.
1 infusion visit with multiple blood sample collections over 30 minutes and at 24 hours post-infusion
Duration - Up to 90 days post-infusion
Participants undergo blood sample collections to measure red blood cell recovery and lifespan, with monitoring for adverse events up to 90 days post-infusion.
Multiple visits including samples at 24 hours, 48 hours, 72 hours, 7 days, and weekly through 35 days post-infusion, plus a final visit at Day 90
Trial Site Locations
Total: 2 locations
1
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267
Not Yet Recruiting
2
American Red Cross Research Laboratory
Norfolk, Virginia, United States, 23510
Actively Recruiting
Research Team
M
Margaret Hennig, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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