A groundbreaking therapeutic advancement has received approval for the treatment of acute kidney injury resulting from sepsis in children.
Sepsis, a grave condition triggering life-threatening organ dysfunction, presents a significant challenge. However, a novel treatment offers hope for the numerous children affected by acute kidney injury stemming from sepsis annually.
Developed at the University of Michigan, the Selective Cytopheretic Device (SCD), also known as Quelimmune, has recently gained clearance from the Food and Drug Administration (FDA). This approval enables its use in pediatric cases involving acute kidney injury and sepsis, or instances necessitating continuous kidney replacement therapy, such as dialysis with an artificial kidney, within intensive care settings.
Sepsis instigates an extreme immune response, releasing toxins into the bloodstream and prompting inflammation, which can lead to organ failure and, frequently, mortality. Despite antibiotics, mortality rates remain high once sepsis progresses to the bloodstream, affecting vital organs like the heart, lungs, kidneys, and liver.
The innovative treatment targets the dysregulated immune system, which is overactive and contributes to tissue damage. During dialysis, the device integrates into the blood, selectively calming excessively activated white blood cells, key drivers of the immune reaction.
By employing pharmacologic manipulation, the device identifies and pacifies these aberrant white cells before reintroducing them into circulation within the body.
Dr. H. David Humes, a professor of nephrology and internal medicine involved in the development in a news release, emphasizes the technology’s focus on addressing the immunological response rather than targeting bacteria. This approach marks a significant breakthrough in treatment.
Clinical trials have demonstrated the device’s ability to mitigate tissue damage, reverse sepsis progression, and enhance survival rates. Furthermore, it exhibits a favorable safety profile, with no instances of device-related infections or serious adverse events noted.
In the United States, nearly 2 million individuals, including 75,000 children develop sepsis annually, surpassing the incidence of heart attacks or strokes. Sepsis claims approximately 250,000 lives annually, including 7,000 children, exceeding the combined toll of pediatric cancers.
Researchers are striving to develop effective treatments, with the SCD offering promise in reducing sepsis-related fatalities and improving patient outcomes.
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