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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled, Single-Blind, 2-Period Crossover Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells

Conditions
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Focus: Assess Post Infusion Viability of S303 RBCs

Intervention / Treatment
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* Biological: S303 Red Blood Cells (RBCs)
* Biological: Conventional, untreated Red Blood Cells (RBCs)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S303 Red Blood Cells (RBCs)<br>Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs). | Biological: S303 Red Blood Cells (RBCs)<br>* 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.<br>Biological: Conventional, untreated Red Blood Cells (RBCs)<br>* 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.<br>|
| Active Comparator: Conventional, Untreated Red Blood Cells (RBCs)<br>Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs). | Biological: S303 Red Blood Cells (RBCs)<br>* 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.<br>Biological: Conventional, untreated Red Blood Cells (RBCs)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days | 24 hour post-infusion recovery of autologous RBCs stored for 35 days (assessed using the Food and Drug Administration (FDA)) criteria for evaluation of in vivo RBC studies) | 70 Days | 
| Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs) | Incidence of antibody specific to S 303 treated RBCs | 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety: Incidence of adverse events | Incidence of adverse events | 70 Days | 
| Secondary Efficacy Endpoint | Mean lifespan of autologous red blood cells (RBCs) | 70 days | 
| Secondary Efficacy Endpoint: | Median lifespan (T50) of autologous red blood cells (RBCs) | 70 days | 
| Secondary Efficacy Endpoint | Area under the curve (AUC) derived from data points collected for the red blood cell (RBC) lifespan | 70 days |