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RECRUITING
NCT07015437
PHASE2

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

Sponsor: Cerus Corporation

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-09-19

Completion Date

2026-10-15

Last Updated

2025-10-15

Healthy Volunteers

Yes

Interventions

DEVICE

INTERCEPT Blood System for RBCs

RBCs treated with the INTERCEPT Blood System for RBCs

OTHER

Infusion of autologous radiolabeled RBCs

Subject will receive a single intravenous infusion of approximately 10 to 30 mL of autologous Day 35 51Cr radiolabeled RBCs and fresh 99mTc RBCs.

Locations (2)

Hoxworth Blood Center

Cincinnati, Ohio, United States

American Red Cross Research Laboratory

Norfolk, Virginia, United States