Methods for managing adverse events in patients with inflammation
Inventors
Dunham, Andrew • Yoshida, Tatsuro • Sowemimo-Coker, Samuel O.
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Assignees
MemberHemanextHemanextHemanext 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.
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-12447177-B2
Publication Date
2025-10-21
Expiration Date
Abstract
Methods for prevention and reversal of inflammation.
Core Innovation
The invention relates to therapeutic use of oxygen-reduced and oxygen-and-carbon-dioxide-reduced stored red blood cells, maintained at low oxygen saturation, including 20% or less during storage and specified pCO2 for OCR, for transfusion therapy. It treats patients having both elevated C-reactive protein and inflammation, including those with a CRP level between 5 and 10 mg/L prior to administering, and reduces elevated CRP relative to conventionally stored, non-oxygen reduced blood.
It reports preservation of ATP and 2,3-DPG during storage, higher 24-hour red blood cell recovery, reduced hemolysis and microparticles, and improved deformability in sickle plasma. The disclosure shows decreased red blood cell adhesion to thrombospondin, VCAM-1, and laminin, addressing vaso-occlusion in sickle cell disease, with compatible additive solutions and embodiments and kits for storage and administration of oxygen-reduced or oxygen- and carbon-dioxide-reduced blood.
Preclinical rat hemorrhagic-shock and ex vivo sickle-plasma studies demonstrate faster restoration of hematocrit and mean arterial pressure with less transfused volume and rapid reductions in lactate and glucose. The invention lowers organ-injury and inflammatory biomarkers including AST, ALT, urinary NGAL, creatinine, BUN, CD45+ neutrophils, CXCL1, IL-6, IL-8, IL-10, G-CSF, and CRP, with increases in CCL-5 and CXCL-10, and provides [procedural detail omitted for safety].
Claims Coverage
One independent claim defines three main inventive features.
Administering stored oxygen-reduced blood with oxygen saturation of 20% or less during storage
Administering stored oxygen-reduced blood that has an oxygen saturation of 20% or less during storage.
Patient selection with elevated CRP level of 5–10 mg/L and inflammation
Treating a patient who has both elevated C-reactive protein (CRP) and inflammation, wherein the elevated CRP level is between 5 and 10 milligrams per liter (mg/L) prior to administering.
Therapeutic outcome of at least 20% CRP reduction versus conventionally stored, non-oxygen reduced blood
Administering the stored oxygen-reduced blood reduces the elevated CRP level in the patient by at least 20% relative to a patient having both elevated CRP and inflammation and having been administered conventionally stored, non-oxygen reduced blood.
The independent claim combines a defined stored blood composition, a defined patient population with elevated CRP and inflammation, and a quantified therapeutic outcome of at least a 20% reduction in CRP versus conventionally stored blood.
Stated Advantages
Reduction of elevated CRP by at least 20% relative to conventionally stored, non-oxygen reduced blood, with dependent claim refinements including an absolute post-treatment CRP target of less than 3 mg/L.
Reductions in liver enzymes AST and ALT.
Reductions in kidney injury markers including urinary NGAL, serum creatinine, and BUN.
Reductions in inflammatory cells, chemokines, and cytokines including CD45+ neutrophils, CXCL1, IL-6, IL-8, IL-10, G-CSF, and CRP; increases in CCL-5 and CXCL-10.
Reduces red blood cell adhesion to thrombospondin by at least 10% and to VCAM-1 and laminin.
Preserves ATP and 2,3-DPG during storage and yields higher 24-hour red blood cell recovery.
Restores hematocrit and mean arterial pressure faster with less transfused volume and rapidly reduces lactate and glucose.
Reduces tissue inflammation with reduced neutrophil infiltration; increases deformability while reducing hemolysis in sickle plasma.
Reduces microparticle formation.
Improved clinical outcomes in transfusion recipients including trauma, hemorrhagic shock, sepsis, inflammation, sickle cell disease, and fever.
Documented Applications
Treatment of elevated C-reactive protein (CRP) in a patient with inflammation, specifically where CRP is between 5 and 10 mg/L prior to administering.
Treatment of inflammation by administering stored oxygen-reduced or oxygen-and-carbon-dioxide-reduced red blood cells.
Use in transfusion therapy with packed red blood cells stored under defined low oxygen saturation and pCO2 conditions.
Treatment of hemorrhagic trauma and hemorrhagic shock.
Treatment of low mean arterial pressure.
Use in sepsis and systemic inflammation, including acute and chronic inflammation.
Treatment of organ injury and inflammation.
Use in sickle cell disease to reduce vaso-occlusive episodes, dactylitis, pain crises, and red blood cell adhesion to thrombospondin, VCAM-1, and laminin, and to increase deformability in sickle plasma.
Treatment of inflammation arising from specified etiologies including trauma, infection, cancer, coagulopathy, and autoimmunity.
Application to patients with fever as described in claim refinements noting increased levels of IL-6, IL-8, IL-10, and G-CSF compared to similarly inflamed patients without fever.
Use of kits and storage/administration embodiments, including oxygen-impermeable storage bag and gas-addition device for producing oxygen-reduced or oxygen- and carbon-dioxide-reduced blood.
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