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A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells

NCT01711346 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-12-16

No results posted yet for this study

Summary

The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to conventional untreated RBCs stored for 35 days.

Conditions

  • Focus: Assess Post Infusion Viability of S303 RBCs

Interventions

BIOLOGICAL

S303 Red Blood Cells (RBCs)

Each subject will receive one intravenous infusion of autologous radiolabeled S303 Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.

BIOLOGICAL

Conventional, untreated Red Blood Cells (RBCs)

Each subject will receive one intravenous infusion of autologous radiolabeled Conventional, untreated Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.

Sponsors & Collaborators

  • Cerus Corporation

    lead INDUSTRY

Principal Investigators

  • Jose A Cancelas-Perez, MD, PhD · Hoxworth Blood Center, Cincinnati, OH

  • Jerome L Gottschall, MD · BloodCenter of Wisconsin, Milwaukee, WI

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-07-31
Completion
2014-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01711346 on ClinicalTrials.gov