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

NCT ID: NCT01711346

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

S303 Red Blood Cells (RBCs)

Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs).

Group Type: EXPERIMENTAL

S303 Red Blood Cells (RBCs)

Intervention Type: BIOLOGICAL

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.

Conventional, untreated Red Blood Cells (RBCs)

Intervention Type: BIOLOGICAL

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.

Conventional, Untreated Red Blood Cells (RBCs)

Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs).

Group Type: ACTIVE_COMPARATOR

S303 Red Blood Cells (RBCs)

Intervention Type: BIOLOGICAL

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.

Conventional, untreated Red Blood Cells (RBCs)

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age at least 18 years, of either gender
• Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
• Complete blood count (CBC); including red blood cell (RBC) indices mean cell volume (MCV), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and RBC distribution width(RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea nitrogen (BUN), creatinine). Values outside of normal reference range thought not to be clinically significant may be allowed with a protocol exception.
• Minimum hemoglobin levels of 13 g/dL for female and 14.5 g/dL for male subjects
• Negative blood donor screening test panel for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), human T cell leukemic virus (HTLV), Syphilis, and west nile virus (WNV) (if available)
• Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
• Meet or exceed American Association of Blood Banks (AABB) guidelines for blood donation (with the exception of travel deferrals).
• Signed and dated informed consent form

Exclusion Criteria

• • Clinically significant acute or chronic disease (as determined by the Investigator)

• History of RBC autoantibodies/autoimmune hemolytic anemia, RBC allo-antibodies, or autoimmune disease
• History of congenital red cell disorders including glucose 6 phosphate dehydrogenase (G-6PD) deficiency
• Serum ferritin <12 ng/mL
• Positive direct antiglobulin test (DAT) or indirect antiglobulin test (IAT) at study entry
• Immunosuppressive therapy (e.g., oral or Intravenous (IV) prednisone) within the past 28 days
• Treatment with any medication known to affect RBC viability
• Pregnant or nursing female
• Male subjects or female subjects of childbearing potential not using effective contraception
• Participation in another clinical study currently or within the past 28 days
• Prior exposure to S 303 treated RBCs
• Pre-existing antibody specific to S 303 treated RBCs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cerus Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose A Cancelas-Perez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hoxworth Blood Center, Cincinnati, OH

Jerome L Gottschall, MD

Role: PRINCIPAL_INVESTIGATOR

BloodCenter of Wisconsin, Milwaukee, WI

Locations

Hoxworth Blood Center

Cincinnati, Ohio, United States

BloodCenter of Wisconsin Inc.

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

CLI 00073

Identifier Type: -

Identifier Source: org_study_id