Paul M. Ness, MD, discusses the goal of the Hemanext ONE® blood storage system and the potential benefit of this approach for those with myelodysplastic syndrome and other conditions that require transfusions.
Processing and storing red blood cells (RBCs) in a hypoxic state may help maintain the integrity of the cells and enhance their efficacy, according to Paul M. Ness, MD, who added that this storage approach could improve the metabolic quality of stored cells, which could translate to improved outcomes for patients with myelodysplastic syndrome (MDS) and other conditions that require transfusions.
Although various storage approaches have allowed for cells to be stored for up to 42 days, when oxygen permeates bag, the cells can be damaged rendering them potentially less beneficial for those who receive them. The Hemanext ONE® system was designed to reduce progressive damage to RBCs during storage.
“The goal was to come up with a way to store blood that would keep cells more intact, prevent hemolysis, [have the blood] last longer in the patient, and deliver oxygen more rapidly,” Ness said. “A series of studies found that over time, the oxygen in the red cells causes damage to the cells. [Bearing this in mind, they tried to come up with an] approach that would store blood hypoxically, or with limited oxygen, so that the cells might last longer and deliver oxygen more rapidly.”
In an interview with OncLive®, Ness, senior director, Division of Transfusion Medicine, professor of Pathology, professor of pathology, medicine and oncology, at Johns Hopkins University, discusses the goal of the Hemanext ONE RBC Processing and Storage System, what makes this product unique from other storage products, and the potential benefit of this approach for those with MDS and other conditions that require transfusions.
Ness: Red blood cells have routinely been stored in refrigerators with various anticoagulants; this has allowed it to be stored for longer. With the utilization of various approaches, we have reached 42 days of storage; this is adequate for most civilian or military blood supplies. [It is] important [to consider whether] the blood continues to carry oxygen and [whether it will] survive in the recipient in an adequate way.
It has been known that the existing methods [in which] blood is collected and stored cause an initial amount of red cell damage and damage over time. If you look at these cells under a microscope, during storage periods, they lose their biconcave disc shape and become abnormal. Therefore, at the end of storage, the blood does not last as long in the patient, and it probably is not as good for the patient.
There was concern [after] studies suggested that older blood might cause patient harm. A lot of clinical trials have been done to contest those findings, which were originally proposed in the New England Journal by [researchers from] the Cleveland Clinic. Blood [storage] with current methods are largely safe, and probably do not harm patients, but [the damage done to red cells with such methods is] clearly not normal.
Hemanext is a company that is trying to develop this technology. [The product] is approved for use in Europe; [however it is] not yet FDA approved. Preliminary studies that have been done in humans suggest that when you store blood in the Hemanext storage bag, the cells will survive longer in the patient. If you look at the morphology of the cells, there will be less oxidative damage to the red cells that have been stored hypoxically.
The company is getting started on several clinical trials, which hopefully will confirm the in vitro research, which has been extensive. Hopefully, these efforts will confirm [that this storage method leads to longer cell] survival time in patients. [Additionally], in patients for whom oxygen delivery is critical immediately, this may [occur more] rapidly with [this Hemanext ONE RBC Processing and Storage System] compared with others that are available.
MDS is a target [patient populations] for these clinical trials because many patients with this disease fail to make red cells, and they become transfusion dependent. Some patients may need as many as 3 or 4 units of blood in a month to maintain some quality of life.
It is hoped that with the Hemanext product, if [the red cells] do survive longer, then the patient can potentially be transfused less frequently. They would then not have to come into the clinic as often, [which is] particularly [beneficial] for elderly patients in the COVID era.
Additionally, patients with MDS who are chronically transfused end up accumulating iron. If we can lower the amount of iron they are exposed to by transfusions, then we may reduce some of the damage from iron overload that can occur. Again, patients with MDS are clearly one of the initial [target populations] that the clinical studies [will focus on].