What this study is
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.
What's being tested
- INTERCEPT Blood System for RBCs
Intervention · DEVICE
RBCs treated with the INTERCEPT Blood System for RBCs
- Infusion of autologous radiolabeled RBCs
Intervention · OTHER
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 details
- Official title
- 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
- Sponsor
- Cerus Corporation
- Conditions
- Healthy Subjects
- Enrolling
- 120 people
- Starts
- 2025-09-19
- Est. completion
- 2027-02-13
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openHoxworth Blood Center
Cincinnati, Ohio, United States
- Neeta Rugg · Contact
Not yet recruitingAmerican Red Cross Research Laboratory
Norfolk, Virginia, United States
- Bethany Brown, Ph.D., MSCS · Contact
Recruiting
Study team
Sponsor
Cerus Corporation
Study ID CLI 00182
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.