5 Clinical Trials for Various Conditions
The purpose of this study is to validate that single units of RBCs collected by the Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using LN832 disposable sets for this intended use.
The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion therapy through novel storage methods potentially improving their quality across the storage cycle. Based on our review of the pertinent literature, there is substantial evidence suggesting that prolonged exposure to oxygen during storage results in oxidative damage to the red blood cells (RBC) over the course of storage leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood cell products prior to storage has potential to preserve the cells in a more physiologically relevant state and improve the clinical outcomes of patients that receive blood transfusions in a variety of therapeutic realms1. Currently, Hemanext Inc. has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System (Hemanext). After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) in AS-3 additive solution, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) processing bag which allows for the rapid diffusion of oxygen out of the blood, through a sterile, oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood is transferred again from the ORB into the Hemanext Storage Bag (HSB) which will preserve the hypoxic state of the LR-RBC product for the duration of cold storage. The COVID-19 crisis has placed unprecedented pressure on the US blood supply security. The pandemic has caused blood supplies to fall precipitously, placing all transfusion recipients at acute risk. Hemanext has developed a technology over 12 years with support from 6 NIH grants and contracts that can substantially mitigate the damage done to the blood supply by this COVID-19 crisis and strengthen the ability of the US blood supply to withstand the effects of future crises. Limited shelf life is a key component in exacerbating the current blood supply crisis. Successful completion of this project will allow earliest possible availability (within 9-12 months) of the high quality Hemanext RBC with significantly extended shelf life. Even without shelf life extension, the higher quality Hemanext RBC showed a reduction of \>50% of blood volume required for resuscitation from hemorrhage in a pre-clinical rodent model. Further enhancement of the quality of Hemanext RBC is expected to improve still further the efficacy of Hemanext blood and further to reduce the transfusion volume needed to achieve treatment objectives. In addition, extending the shelf life of the Hemanext RBC will provide greater inventory flexibility to avoid the devastating impact of major blood shortages due to reduced donor activity during threats to blood security such a COVID-19 pandemics and other crises.
Primary Hypothesis * The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet FDA standards for clinical use. * The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron repletion will improve significantly and will meet FDA standards for clinical use.
The primary goal of Hemanext. is to improve red cell storage through novel storage methods. Based on our review of the pertinent literature, there is substantial evidence suggesting that prolonged exposure to oxygen during storage results in oxidative damage to the red blood cells leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood cell products prior to storage has potential to preserve the cells in a more physiologically relevant state. Currently, Hemanext has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System. After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) with the appropriate additive solutions, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) which allows for the rapid diffusion of oxygen out of the blood, through a sterile, oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood is transferred again from the ORB into the Hemanext storage bag (HSB) which will preserve the anaerobic state of the LR-RBC product for the duration of cold storage. Hemanext has conducted preliminary storage tests to ascertain the effects of anaerobic storage on overall blood health in various storage solutions. The research team has focused primarily on percent hemolysis, which is mandated by the FDA to remain below 1% for the duration of storage, as well as ATP and 2,3-DPG levels.
Blood donation has been proposed to be associated with reduced risk of cardiovascular disease, but the effects of phlebotomy on vascular function in human subjects have not been well characterized. A prospective randomized double-blind study was undertaken to determine the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular endothelial function in the brachial artery.