In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days

PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

April 16, 2021

Study Completion Date

April 17, 2021

Conditions
Healthy
Interventions
DEVICE

INTERCEPT Treated Platelets

Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) will be simultaneously administered intravenously into the subject.

Trial Locations (2)

45221

Hoxworth Blood Center, Cincinnati

98102

Bloodworks Northwest Research Institute, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cerus Corporation

INDUSTRY