RecruitingPhase 2NCT07015437

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

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

Enrollment

70 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called INTERCEPT Blood System for RBCs and Infusion of autologous radiolabeled RBCs for people with healthy subjects. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEINTERCEPT Blood System for RBCs

RBCs treated with the INTERCEPT Blood System for RBCs

OTHERInfusion 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

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NCT07015437


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