Methods for the storage of whole blood, and compositions thereof

Inventors

Yoshida, Tatsuro

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Assignees

Hemanext Inc

Member
Hemanext
Hemanext

Hemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.

Publication Number

US-11013771-B2

Patent

Publication Date

2021-05-25

Expiration Date


Abstract

Methods and compositions for improved clinical outcomes for trauma patients receiving whole blood transfusion. Methods and compositions for improved clinical outcomes for blood transfusions for cancer patients are also provided.

Core Innovation

The patent describes oxygen-reduced (OR) and oxygen-and-carbon-dioxide-reduced (OCR) leukoreduced whole blood products stored under anaerobic conditions prior to refrigerated storage. These products preserve coagulation factor activity (≥75% vs conventional), maintain or enhance platelet function, increase or retain 2,3-DPG and ATP, reduce inflammatory cytokines notably RANTES and eotaxin, lower cell-free hemoglobin and isoprostane, improve red blood cell deformability and microvascular perfusion, extend shelf life to ≥3 weeks, and permit recycling into OR packed red blood cells.

The disclosure provides [procedural detail omitted for safety], describes acceptable anticoagulants and additive solutions, and integrates massive transfusion kit compositions with blood-bank inventory and recycling strategies. It addresses deficiencies of conventionally stored leukoreduced whole blood with platelets, which accumulates storage-lesion markers and pro-inflammatory cytokines and undergoes declines in 2,3-DPG, ATP, coagulation and platelet function, and red blood cell deformability, by depleting oxygen or oxygen and carbon dioxide prior to storage.

Claims Coverage

The patent includes two independent claims and five inventive features that focus on transfusing oxygen and carbon dioxide reduced leukoreduced whole blood with platelets (OCR-LRWB+PLT) to improve survival or reduce inflammatory response, inclusion of an anticoagulant, and the product exhibiting reduced inflammatory cytokines after anaerobic storage with specific cytokine reductions.

Transfusion of OCR-LRWB+PLT to improve survival

A method for improving survival of a patient in need of multiple transfusions comprising transfusing stored oxygen and carbon dioxide reduced leukoreduced whole blood with platelets (OCR-LRWB+PLT) to a patient in need of receiving multiple whole blood transfusions.

Product comprising an anticoagulant

The OCR-LRWB+PLT product comprises an anticoagulant when transfused to the patient in need of receiving multiple whole blood transfusions.

Transfusion of OCR-LRWB+PLT to reduce inflammatory response

A method of reducing an inflammatory response in a patient in need of a blood transfusion comprising transfusing oxygen and carbon dioxide reduced and leukoreduced whole blood with platelets (OCR-LRWB+PLT) to said patient in need thereof.

OCR-LRWB+PLT with reduced inflammatory cytokines after anaerobic storage

The OCR-LRWB+PLT product exhibits reduced levels of inflammatory cytokines after storage under anaerobic conditions compared to conventionally stored leukoreduced whole blood with platelets (LRWB+PLT).

Specific cytokine reductions (RANTES and eotaxin)

Reduction in levels of specific inflammatory cytokines eotaxin or RANTES in OCR-LRWB+PLT compared to conventionally stored LRWB+PLT.

The independent claims focus on transfusing OCR-LRWB+PLT to improve survival or reduce inflammatory response, specify inclusion of an anticoagulant, and rely on OCR-LRWB+PLT exhibiting reduced inflammatory cytokines after anaerobic storage relative to conventional LRWB+PLT, including reductions in RANTES and eotaxin.

Stated Advantages

Preservation of coagulation factor activity (≥75% vs conventional).

Preserves and increases 2,3-diphosphoglycerate (2,3-DPG) and adenosine triphosphate (ATP) in stored blood products.

Reduces storage-lesion markers including cell-free hemoglobin and isoprostane.

Reduces pro-inflammatory and pro-cancer cytokines, notably RANTES (CCL5), eotaxin (CCL11), MCP-1, TNF-α, PDGF, sCD40L, angiogenin, and EGF.

Maintains coagulation and platelet hemostatic function [procedural detail omitted for safety].

Maintenance or enhancement of platelet function.

Improves red blood cell deformability and microvascular perfusion.

Extends usable shelf life to ≥3 weeks.

Permits recycling of unused OR whole blood into OR packed red blood cells.

Reduction of inflammatory response in transfused patients.

Improvement in survival for patients in need of multiple transfusions.

Documented Applications

A method for improving survival of a patient in need of multiple transfusions by transfusing OCR-LRWB+PLT.

A method of reducing an inflammatory response in a patient in need of a blood transfusion by transfusing OCR-LRWB+PLT that has reduced inflammatory cytokines after anaerobic storage.

Use in defined patient subgroups needing multiple transfusions including trauma patients, transplant patients, cardiac surgery patients, obstetrics patients, GI surgery patients, cancer patients, and orthopedic surgery patients.

Use for recipients of massive transfusion.

Massive transfusion kit (MTK) compositions incorporating the OR/OCR leukoreduced whole blood products.

Blood-bank inventory and recycling strategies integrating the processing and storage workflows for OR/OCR products.

Clinical indications related to improved survival including perioperative cancer (pancreatic) and trauma indications with reduced MODS as described.

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