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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
• Clinically significant acute or chronic disease (as determined by the Investigator)
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| Name | Affiliation | Role |
|---|---|---|
| Jose A Cancelas-Perez, MD, PhD | Hoxworth Blood Center, Cincinnati, OH | Principal Investigator |
| Jerome L Gottschall, MD | BloodCenter of Wisconsin, Milwaukee, WI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoxworth Blood Center | Cincinnati | Ohio | 45267-0055 | United States | ||
| BloodCenter of Wisconsin Inc. |
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| 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. |
|
| 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 |
| Milwaukee |
| Wisconsin |
| 53201 |
| United States |
| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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