US 12,295,972 B2
Methods using freeze-dried platelet derivative compositions for restoring hemostasis in a subject
Keith Andrew Moskowitz, Westfield, IN (US); Braden Carl Ishler, Montgomery Village, MD (US); William Matthew Dickerson, Washington, DC (US); Narendra Nath Tandon, Gaithersburg, MD (US); Amber Nicole Lee, Montgomery Village, MD (US); Stephen Edward Amos, Buckeystown, MD (US); Rafael Jorda, Merignac (FR); and Michael Alexander Mathews, Arlington, VA (US)
Assigned to Cellphire, Inc., Rockville, MD (US)
Filed by Cellphire, Inc., Rockville, MD (US)
Filed on Aug. 20, 2024, as Appl. No. 18/810,381.
Application 18/810,381 is a continuation of application No. 17/674,770, filed on Feb. 17, 2022.
Claims priority of provisional application 63/264,227, filed on Nov. 17, 2021.
Claims priority of provisional application 63/276,420, filed on Nov. 5, 2021.
Claims priority of provisional application 63/275,937, filed on Nov. 4, 2021.
Claims priority of provisional application 63/150,338, filed on Feb. 17, 2021.
Prior Publication US 2024/0408141 A1, Dec. 12, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 35/19 (2015.01); A61K 9/19 (2006.01); A61P 7/04 (2006.01)
CPC A61K 35/19 (2013.01) [A61K 9/19 (2013.01); A61P 7/04 (2018.01)] 30 Claims
 
1. A method for restoring hemostasis in a subject, wherein the method comprises:
rehydrating a platelet derivative composition in the form of a powder, said composition comprising an effective amount of the platelet derivatives and an incubating agent comprising one or more saccharides, one or more salts, and a buffer to form a rehydrated platelet derivative composition, and
administering the rehydrated platelet derivative composition comprising the effective amount of the platelet derivatives to the subject,
wherein the subject has been treated or is being treated with at least one antiplatelet agent,
wherein at least 70% of the platelet derivatives in the rehydrated platelet derivative composition are CD41 positive platelet derivatives when measured using flow cytometry, and less than 5% of the CD41 positive platelet derivatives are microparticles,
wherein at least 70% of the platelet derivatives in the rehydrated platelet derivative composition are CD42 positive platelet derivatives, when measured using flow cytometry,
wherein at least 70% of the platelet derivatives in the rehydrated platelet derivative composition are CD62 positive platelet derivatives, when measured using flow cytometry,
wherein the platelet derivatives are capable of generating thrombin in an in vitro thrombin formation assay,
wherein the platelet derivatives have in vitro occlusion activity, and
wherein the platelet derivatives show an inability to increase expression of a platelet activation marker in the presence of an agonist as compared to the expression of the platelet activation marker in the absence of the agonist, and wherein the agonist is thrombin receptor activator peptide 6 (TRAP-6) and the platelet activation marker can be detected by binding of Annexin V to the platelet derivatives.