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HHS funds development of freeze-dried platelets for disaster response
New product could improve care for Acute Radiation Syndrome and daily medical care
Date: September 20, 2013
Organization: Cellphire Inc. of Rockville, Md.
Funding: This contract is for $11 million in the first 18 months and can be extended if milestones are met for a total of up to five years and up to $56.7 million.
About this contract: Cellphire will further develop Thrombosomes as a possible treatment for acute radiation syndrome. Thrombosomes is a novel freeze-dried blood product derived from human platelets.
Using a proprietary stabilization method, Cellphire can convert platelets into a powder that can be stored at room temperature for extended periods. When the product is needed, the powder can be reconstituted rapidly using sterile water and injected to restore normal clotting.
As a freeze-dried product, Thrombosomes may be easier to store, transport, and deploy than the current platelet product, and hold the potential to improve day-to-day emergency care and emergency response to a disaster.
Platelets are cell fragments found in the blood and are largely responsible for clotting. Platelet transfusions can prevent or treat bleeding in patients whose own platelets are dysfunctional or whose platelet counts are below a critical threshold. This condition, known as thrombocytopenia, can result from exposure to large doses of radiation and may result in life-threatening hemorrhage.
Platelet units processed from donated blood using current technology have a shelf life of five days at room temperature and cannot be refrigerated. Processing, testing for infectious disease, and quality checks can take up to two days. This short shelf-life of platelet units creates a logistical challenge in using platelets and could lead to a shortfall in a mass casualty event.
During the initial phase of the project, Cellphire will optimize their manufacturing processes, evaluate the product?s stability, and test the product?s efficacy in non-clinical trials. Initial work also includes clinical trials to demonstrate safety.
In later phases of the project, the company may conduct Phase 1 and 2 clinical trials with additional non-clinical efficacy studies as necessary for regulatory approval. The work supported by this contract builds on research and development supported by the U.S. Department of Defense.
No drugs or medical products are currently approved by the U.S. Food and Drug Administration for use in treating the effects of ARS.
Thrombosomes also may find use in daily emergency medical care.
http://www.phe.gov/Preparedness/mcm/Pages/platelets-1309.aspx
HHS funds development of freeze-dried platelets for disaster response
New product could improve care for Acute Radiation Syndrome and daily medical care
Date: September 20, 2013
Organization: Cellphire Inc. of Rockville, Md.
Funding: This contract is for $11 million in the first 18 months and can be extended if milestones are met for a total of up to five years and up to $56.7 million.
About this contract: Cellphire will further develop Thrombosomes as a possible treatment for acute radiation syndrome. Thrombosomes is a novel freeze-dried blood product derived from human platelets.
Using a proprietary stabilization method, Cellphire can convert platelets into a powder that can be stored at room temperature for extended periods. When the product is needed, the powder can be reconstituted rapidly using sterile water and injected to restore normal clotting.
As a freeze-dried product, Thrombosomes may be easier to store, transport, and deploy than the current platelet product, and hold the potential to improve day-to-day emergency care and emergency response to a disaster.
Platelets are cell fragments found in the blood and are largely responsible for clotting. Platelet transfusions can prevent or treat bleeding in patients whose own platelets are dysfunctional or whose platelet counts are below a critical threshold. This condition, known as thrombocytopenia, can result from exposure to large doses of radiation and may result in life-threatening hemorrhage.
Platelet units processed from donated blood using current technology have a shelf life of five days at room temperature and cannot be refrigerated. Processing, testing for infectious disease, and quality checks can take up to two days. This short shelf-life of platelet units creates a logistical challenge in using platelets and could lead to a shortfall in a mass casualty event.
During the initial phase of the project, Cellphire will optimize their manufacturing processes, evaluate the product?s stability, and test the product?s efficacy in non-clinical trials. Initial work also includes clinical trials to demonstrate safety.
In later phases of the project, the company may conduct Phase 1 and 2 clinical trials with additional non-clinical efficacy studies as necessary for regulatory approval. The work supported by this contract builds on research and development supported by the U.S. Department of Defense.
No drugs or medical products are currently approved by the U.S. Food and Drug Administration for use in treating the effects of ARS.
Thrombosomes also may find use in daily emergency medical care.
http://www.phe.gov/Preparedness/mcm/Pages/platelets-1309.aspx