Hemanext
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Extending the Shelf Life of Donated Blood
June/July 2008
Los Alamos scientists and a public-sector company are making progress
By Marjorie Mascheroni
Most of us take for granted the fact that should we ever need a blood transfusion to save our life, the blood will be available and it will be safe. In the United States alone, over 14 million units of blood are collected annually from approximately 8 million volunteers and transfused into over 5 million individuals whose lives usually depend on receiving the precious elixir.
Yet, prior to World War II, the practice of transfusing blood as a life-saving procedure was rare. It was not until the late 1930s and early 1940s that an effective way was found to store donated blood. The discovery by American physician and medical researcher Dr. Charles R. Drew that blood could be separated into blood plasma and red blood cells and the components frozen separately was a major advancement in blood storage. In 1950, the introduction of the plastic bag for blood collection, replacing breakable glass bottles, was an innovation that enabled the evolution of a collection system capable of safe and easy preparation of multiple blood components from a single unit (slightly under a pint) of whole blood. The introduction in 1979 of CPDA-1, an anticoagulant preservative, further extended the shelf life of stored blood helping to increase available blood supplies and facilitating resource sharing among blood banks.
However, despite significant progress in the intervening years toward ensuring the safety of donated blood, little progress has been made toward extending its shelf life—or effectiveness. And, while the Food and Drug Administration approves the use of donated red blood cells up to 42-days old, research conducted at the Cleveland Clinic between June 1998 and January 2006 confirms that “transfusion of red cells that had been stored for more than two weeks was associated with a significantly increased risk of postoperative complications as well as reduced short-term and long-term survival.”
In the mid 1990s, because Los Alamos National Laboratory bio-engineering researchers Mark Bitensky and Tatsuro Yoshida recognized there was a compelling international need to develop technology for safely extending the storage life of red blood cells, the two developed a breakthrough technology that promises to significantly improve this situation. Awarded a patent in 1998 for “Prolonged Cold Storage of Red Blood Cells,” Bitensky and Yoshida’s innovation preserves red blood cell quality and prolongs post-transfusion in vivo survival by depleting the oxygen in the blood at the time of storage. Their work addresses major national and international problems such as patient safety and the cost of medical care. It has important applications in combat casualty care and for preplanned surgery, since its adoption will facilitate the use of patient-donated blood.
Confidence in the breakthrough aspect of this work was high enough that New Health Sciences Inc. of Bethesda, Md., licensed the technology from Los Alamos and has established a new subsidiary, Hemanext LLC, to develop, manufacture, distribute and market a new generation of products invented especially for the storage of human red blood cells.
Hemanext intends to become a major player in the blood storage industry by commercializing the Los Alamos invention, which yields deoxygenated blood that remains in excellent condition for 12 weeks at 4C. According to tests conducted using the Los Alamos oxygen depletion process, this process results in a blood storage product whose biochemical test scores are significantly better at 12 weeks than those obtained after 6 weeks of conventional storage. The practice of oxygen-depleted storage to keep products “fresh” is widespread in the food and pharmaceutical industries. Although nearly all animal cells require oxygen for their survival, the red blood cell is a rare exception. The Los Alamos invention exploits this unique property of red blood cells to store them under oxygen-depleted conditions, reducing oxidative damage and enhancing metabolic function.
According to New Health Sciences CFO Barret Hildebrand, “Hemanext has the potential not only to extend the useful shelf life of red blood cells by 50 to 100 percent, but also to improve the quality, hence, the safety, of blood. We absolutely consider this to be a breakthrough technology.”
The innovation involves nearly depleting blood oxygen levels prior to storage by flushing the cells with an inert gas and storing them in an oxygen-depleted condition in a storage solution. By reducing to practice the technology invented and patented at the laboratory and further developed at Boston University, Hemanext plans to implement the technology by developing a new blood storage system that can be easily assimilated into current blood banking practices.
One of the major problems associated with current storage practices is the deterioration of red blood cells (development of storage lesions) during standard refrigerated storage. Mature red blood cells circulate for approximately 120 days in the human body, become senescent (aged), and are removed by the spleen. When stored at 4C in a blood storage bag, away from the stress of the constantly cycling environment of circulation, the cellular senescence process is partially suspended. However, during standard cold temperature storage, depressed activities of protective enzymes and a lack of constant nutrient replenishment and waste removal causes red blood cells to gradually deteriorate, resulting in compromised physiological functions.
These stora Innovation ge lesions are observed as altered biochemical and physical parameters associated with stored cells. The damaged cells are either hemolyzed (disintegrated) during storage or in the body shortly after transfusion, resulting in reduced 24-hour post-transfusion survival. The hemolysis and 24-hour post transfusion survival rates are two measures used by the FDA to test the performance of red cell storage procedures. Although limited data are available, under standard storage conditions, researchers have found that the 24-hour survival rate declines gradually with increased storage time. As noted earlier, the storage limit is reached after 6 weeks (42 days) for conventionally stored red blood cells.
Using the new process, Hemanext will reduce the rate of storage lesion development by storing red blood cells under oxygen-depleted (anaerobic) conditions in optimized storage solutions. The effects of the anaerobic storage process are evidenced by significantly improved biochemical/biomechanical parameters observed during extended storage. By using a conventional storage solution, Hemanext researchers have demonstrated that anaerobic storage is capable of extending blood shelf life to 9 weeks. A series of FDA Phase I/II clinical trials have shown that red blood cells stored in modified storage solution under the anaerobic storage system has prolonged acceptable shelf life by 50 to 100 percent compared with current methods. Moreover, when 24-hour recoveries were compared between red blood cells stored under conventional and under anaerobic conditions after 6 weeks of storage, anaerobically stored red blood cells had significantly higher recovery rates.
To date, in FDA Phase I/II clinical trials, Hemanext has accomplished the following with anaerobic storage: extending the shelf life of refrigerated red blood cells by 50 percent (to 9 weeks) using a storage solution currently in wide use; extending the shelf life of refrigerated red blood cells by 100 percent (to 12 weeks) using advanced storage solution coupled with metabolic supplementation during storage; and extending the shelf life of refrigerated red blood cells by 50 percent (to 9 weeks) using advanced storage solution. In addition, Hemanext has demonstrated in one of these clinical trials that, after 6 weeks of storage, its storage system resulted in a significantly increased post-transfusion, 24-hour survival rate compared with recovery rates for conventionally stored red blood cells.
While Hemanext still has some regulatory and engineering hurdles to clear before launching its revolutionary blood storage system, the successful commercialization of this breakthrough product will yield two vitally important benefits to patients and to the healthcare system. The first is a reduction in the cost of blood that will be achieved by reducing the volume of blood discarded due to age and reducing logistics costs currently incurred to move blood from low-use to high-use areas to reduce the amount of blood discarded due to age.
The second, and most important, benefit is a reduction in the number of medical complications caused by transfusing patients with lower quality, conventionally stored blood, thereby improving short- and long-term patient outcomes and reducing treatment costs.
Marjorie Mascheroni is a LANL information specialist.