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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Cerus Corporation
Study ID
NCT07015437
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • INTERCEPT Blood System for RBCs — DEVICE
    RBCs treated with the INTERCEPT Blood System for RBCs
  • Infusion of autologous radiolabeled RBCs — 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

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 Dates

Start date
Sep 19, 2025
Status verified
Oct 2025
Primary completion
Jul 30, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Test RBCs will be prepared with the INTERCEPT Blood System for RBCs
    One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Test treatment arm for preparation of the Test RBCs. The Test RBCs will be prepared with the INTERCEPT Blood System for RBCs with AS-1, within 24 hours or 25 to 48 hours post collection (depending on randomization assignment) and stored at 1°C to 6°C for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 autologous 51Cr radiolabeled Test RBCs.
  • Experimental: Control RBC components will be prepared according to the site standard operating procedures
    One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Control treatment arm for preparation of the Control RBCs in AS-1. The Control RBC components will be prepared and stored at 1°C to 6°C, according to the site standard operating procedures, for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 51Cr autologous radiolabeled Control RBCs.

Primary Outcome Measure

The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion [ Time Frame: Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hoxworth Blood CenterCincinnatiOhio45267
Neeta Rugg
American Red Cross Research LaboratoryNorfolkVirginia23510
Bethany Brown, Ph.D., MSCS

Find similar trials in Cincinnati, OH

By research site
Hoxworth Blood Center· Cincinnati, OHAmerican Red Cross Research Laboratory· Norfolk, VA

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