Phase II year
2016
(last award dollars: 2018)
Phase II Amount
$2,969,757
The objective of this project is to commercialize the Hemanext Storage System to deliver red blood cells (RBC) of significantly improved quality by establishing and maintaining an anaerobic environment for refrigerated RBC storage. The higher quality red blood cell product will exhibit bioequivalence vs. conventionally prepared RBC with lower doses by virtue of higher RBC recovery, superior microvascular perfusion and oxygen delivery and a reduction in agents implicated in adverse events. The design of the Hemanext Storage System has been informed by detailed study of existing blood bank operating practices to maximize compatibility with existing procedures, equipment use, and cost. The Phase IIB work described below will build on the outcomes achieved in an ongoing Phase II contract. Supported by the Phase II contract, a first generation disposable oxygen reduction and anaerobic storage system was designed and fabricated with the objective of performing the required pivotal clinical studies to achieve FDA clearance. The four aims of this Phase II Bridge proposal are: First, to conduct a pre-pivotal, dual-arm clinical study with 6 subjects under 2 processing conditions. A first generation, IDE-ready commercial device will be tested at Hoxworth Blood Center to both verify the fit of the Hemanext Storage System into pre-storage component processing operations at a blood center and to measure the impact deoxygenation and anaerobic storage have on in vivo recovery and in vitro blood quality parameters. Second, to conduct the pivotal clinical study to support the FDA regulatory submission of the Hemanext Storage System. Hoxworth Blood Center and the American Red Cross Mid-Atlantic Region Research Center in Norfolk are the planned pivotal clinical study sites. Third, to conduct an in vivo recovery study at Columbia University to demonstrate how establishing and maintaining an anaerobic environment mitigates the damage done to red blood cells by irradiation. Fourth, to apply systems biology analytics of red blood cell metabolomics, lipidomics, biomechanics, and vascular bioactivity to identify novel biomarkers that are predictive of in vivo recovery. All studies will be performed, where required, under the authorization of an FDA-compliant IRB.
Public Health Relevance Statement: PUBLIC HEALTH RELEVANCE Blood transfusions save and/or sustain thousands of lives every day in the US and across the globe. Improvements in pathogen screening, storage solutions, and leukocyte reduction have continued to improve the clinical benefits of blood transfusion and reduce the risks. Nevertheless, the biochemical and biomechanical degradation that occurs over the course of six weeks of storage is well established. Though the direct link between the degrading red blood cell and transfusion side effects is not completely understood, a real risk remains that over the course of six weeks of storage a given unit of blood may present a significant risk to a vulnerable patient. By storing blood under oxygen- depleted conditions the Hemanext Storage System reduces this degradation by removing a major root cause: oxidative damage to hemoglobin. In this application, studies are proposed to elucidate and demonstrate the clinical benefits of the Hemanext Storage System in support of FDA market clearance. (End of Abstract)
NIH Spending Category: Bioengineering; Clinical Research; Hematology
Project Terms: abstracting; Adoption; Adverse effects; Adverse event; American; arm; Authorization documentation; base; Biochemical; Biochemistry; Biocompatible; Biological Assay; Biomechanics; Blood; Blood Banks; Blood Transfusion; Blood Vessels; cell injury; Cell physiology; Clinical; Clinical Data; Clinical Research; commercialization; Comparative Study; Contracts; cost; Data; design; Development; Devices; Diffusion; Dose; Effectiveness; Environment; Equipment; Erythrocytes; Exhibits; Gases; Generations; Goals; Graft-vs-Host Disease; Hemoglobin; Hemolysis; Hour; Human; improved; In Vitro; in vivo; innovation; insight; Institutional Review Boards; irradiation; Leukocytes; Link; Marketing; Measures; metabolomics; Mid-Atlantic Region; novel; novel marker; operation; Outcome; oxidative damage; Oxygen; pathogen; Patients; Perfusion; Phase; Physiological; Plant Roots; prevent; Procedures; Process; product development; public health relevance; Recovery; Red Cross; Reporting; Research; Risk; Roentgen Rays; Safety; screening; Side; Site; Surface; System; Systems Biology; T-Lymphocyte; Temperature; Testing; Therapeutic Equivalency; Transfusion; Universities; Whole Blood; Work
