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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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This "first-in-human" exploratory IND, single-center study will assess the safety, toxicity, hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in healthy human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Thrombosomes |
|
| Placebo | Placebo Comparator | Buffer/placebo Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombosomes | Biological | Freeze-dried platelets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety Evaluation | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Hematology, Coagulation and Platelet Immunology Assessment | 60 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fitzpatrick, PhD | Cellphire Therapeutics, Inc. | Study Director |
| Sherrill Slichter, MD | Bloodworks Northwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bloodworks Northwest | Seattle | Washington | 98104 | United States |
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| Biological |
|
|
| ID | Term |
|---|---|
| D002021 | Buffers |
| ID | Term |
|---|---|
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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