A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
Recruiting now · Phase 2
Conditions studied: Healthy Subjects
In brief
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.
Key facts
- Study ID
- NCT07015437
- Run by
- Cerus Corporation
- People needed
- 70
- Starts
- 2025-09-19
- Expected to finish
- 2026-10-15
- Last updated by the study team
- 2025-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- American Red Cross Research Laboratory — Norfolk, Virginia, United States (enrolling)
- Hoxworth Blood Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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