US-12616192-B2 - Compositions and methods for preserving or increasing platelet function

Abstract

Among the various aspects of the present disclosure is the provision of compositions and methods for platelet storage supplementation with an amino acid, such as taurine.

Inventors

• Kimberly Thomas
• Susan Shea
• Philip Spinella

Assignees

• WASHINGTON UNIVERSITY

Dates

Publication Date

20260505

Application Date

20220712

Claims (17)

1. 1 . A composition comprising isolated platelets and about 650 μM to about 1000 μM of taurine or a functional derivative thereof, wherein the composition is stored at about 0 to 8° C.
2. 2 . The composition of claim 1 , further comprising acetate, potassium, magnesium, phosphate, bicarbonate, calcium, citrate, gluconate, glucose, sodium chloride, or any combination thereof.
3. 3 . The composition of claim 1 , wherein the composition is stored at a temperature of about 2 to 8° C.
4. 4 . A method of storing platelets prior to administration into a subject, the method comprising: providing platelets; providing a platelet additive solution comprising about 250 μM to about 1000 μM taurine or a functional derivative thereof; contacting the platelets and the platelet additive solution, resulting in treated platelets; and storing the treated platelets for at least 2 days at a temperature of about 0 to 8° C.
5. 5 . The method of claim 4 , wherein the platelet additive solution further comprises acetate, potassium, magnesium, phosphate, bicarbonate, calcium, citrate, gluconate, glucose, sodium chloride, or any combination thereof.
6. 6 . The method of claim 4 , wherein the treated platelets exhibit an increase in platelet function comprising enhanced platelet aggregation, stabilized platelet mitochondria, increased shelf-life, compared to platelets stored in a solution without the taurine or a functional derivative thereof.
7. 7 . The method of claim 6 , wherein platelet function is measured under flow conditions and wherein the increase in platelet function is measured by an increase in hemostatic function under physiologically relevant flow.
8. 8 . The method of claim 4 , wherein the treated platelets stored in the platelet additive solution are twice-as-fast acting or acts in half the time as platelets stored in a solution without the taurine or functional derivative thereof.
9. 9 . The methods of claim 4 , wherein the platelets are contacted with the platelet additive solution at the beginning of storage or during storage.
10. 10 . The method of claim 4 , wherein the treated platelets are stored for at least 5, at least 7, at least 14, or at least 21 days.
11. 11 . The method of claim 4 , wherein the amount of taurine or functional derivative thereof is about 500 μM.
12. 12 . The method of claim 4 , wherein the treated platelets are stored for about 21 days.
13. 13 . The method of claim 4 , wherein the subject is a cancer patient.
14. 14 . The method of claim 4 , wherein the subject has internal bleeding.
15. 15 . The method of claim 4 , wherein the subject is an actively bleeding patient.
16. 16 . The method of claim 4 , wherein the subject is being treated or has been treated with chemotherapy.
17. 17 . The method of claim 4 , wherein the temperature is about 2 to 8° C.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application 63/220,627, filed Jul. 12, 2021 the disclosure of which is hereby incorporated by reference in its entirety. FIELD OF THE TECHNOLOGY This disclosure generally relates to solutions, methods, and systems for processing isolated platelets, more particularly, for resuspending and/or storing platelet products. BACKGROUND Blood is typically processed to separate various blood components that can be separately used. For example, a unit of donated whole blood can be processed to separate red cells, usually concentrated as packed red cells (PRC), platelets, usually concentrated as platelet concentrate (PC), and plasma. In accordance with typical processing protocols, blood is processed to form, among other fractions, a platelet-containing fluid, e.g., platelet-rich-plasma (PRP) or buffy coat, that are further processed (including centrifugation) to form the PC. Moreover, multiple units of platelets or buffy coat can be pooled before producing the final transfusion product. In accordance with current conventional blood banking practice, PC produced in a closed system can be stored for up to 5 days before being used as a transfusion product. In some processing protocols, a platelet additive solution is added to the platelet-containing fluid (e.g., the buffy coat) and the platelets are resuspended in the additive solution before the platelets are stored, wherein most of the plasma is removed before the additive solution is added. In order to provide optimal platelet function and viability during storage, it is recommended that the platelet-containing fluid (with or without an additive solution) be maintained at a pH in the range of from 6.8 to 7.4 (European practice), or maintained at a pH of 6.2 or greater (US practice) during the storage period. However, platelets may become activated during the processing of blood to concentrate the platelets (including during the subsequent resuspension of the platelets in the additive solution), leading to platelet aggregation and a loss of viable platelets in the transfusion product. Thus, there is a need in the art compositions and methods for resuspending and/or storing platelet products which do not lead to loss of viability and/or function. SUMMARY Among the various aspects of the present disclosure platelet solutions (e.g., storage and/or resuspension) as disclosed herein. Accordingly, one aspect of the present disclosure features a platelet storage solution comprising an amino acid effective to improve or preserve platelet function. Another aspect of the present disclosure provides methods of increasing or preserving platelets during storage, the methods generally comprise providing platelets; providing a platelet storage supplement comprising an amino acid in an amount effective to improve, increase, or preserve platelet function; and contacting the platelets and the composition, resulting in treated platelets. In each of the above aspects the platelets are treated with the composition before administering the treated platelets to a subject. In some embodiments, the platelet storage solution further comprises acetate, potassium, magnesium, phosphate, bicarbonate, calcium, citrate, gluconate, glucose, sodium chloride, or combinations thereof. In some embodiments, the storage solution or methods, the amino acid is taurine or functional variant thereof. In some embodiments, contacting the isolated platelets with the amino acid during storage results in improved, increased, or preserved platelet function by promoting platelet aggregation, stabilizing platelet mitochondria, and/or increasing shelf-life, compared to isolated platelets stored in a solution not supplemented with an amino acid. In some embodiments, platelet function is measured under flow conditions. In some embodiments, an increase in platelet function is measured by an increase in hemostatic function under physiologically relevant flow. In some embodiments, the treated/supplemented platelets are twice-as-fast acting or acts in half the time as unsupplemented platelets. In some embodiments, improved platelet function is measured by increases hemostatic function under physiologically relevant flow. In some embodiments, the platelets are supplemented at the beginning of storage or during storage. In some embodiments, increased platelet function which held over a week of storage. In some embodiments, the platelets are supplemented any time before transfusion into a patient. In some embodiments, the amino acid is taurine. In some embodiments, the amount effective to improve, increase, or preserve platelet function is about 500 μM. In some embodiments, the platelets are stored in cold storage. In some embodiments, the platelets are stored in room temperature storage. In some embodiments, the platelets are stored for up to about 21 days. In some embodiments, the subject is a cancer patient. In some embodiments, th