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S303 Red Blood Cells · 1 trial · 1 indication
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)
Incidence of antibody specific to S 303 treated RBCs
| Arm | Type | Description |
|---|---|---|
| S303 Red Blood Cells (RBCs) | EXPERIMENTAL | Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs). |
| Conventional, Untreated Red Blood Cells (RBCs) | ACTIVE_COMPARATOR | Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs). |
| Name | Type | Description |
|---|---|---|
| S303 Red Blood Cells (RBCs) | 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) | 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. |
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), m...
S-303 Red Blood Cells is an investigational pathogen-reduced red blood cell product being studied for transfusion support in patients with acute anemia. It is designed to assess post-infusion viability of treated red blood cells and evaluate safety and efficacy in patients requiring transfusion support.
Cerus Corporation (NASDAQ: CERS) is developing S-303 Red Blood Cells. The company is conducting clinical trials to evaluate the product's safety and efficacy in transfusion settings.
S-303 Red Blood Cells is in Phase 3 clinical development. A Phase 3 trial has been completed, along with a Phase 2 study, both focused on assessing the product's viability and use in patients with acute anemia.
S-303 Red Blood Cells has been studied in two completed trials: NCT01711346, a Phase 2 study assessing recovery and lifespan of radiolabeled autologous treated red blood cells, and NCT01716923, a Phase 3 study evaluating safety and efficacy in patients requiring transfusion support for acute anemia.
Yes, S-303 Red Blood Cells is also referred to as S303 RBCs. Clinical trial records use both names to describe the same pathogen-reduced red blood cell product developed by Cerus Corporation.