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Results Support Future Study of the Hemopurifier® as Part of a Machine Perfusion Circuit to Further Assess its Association with Function of Retrieved Kidneys
Aethlon Medical, a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced the publication in preprint of an in vitro study in bioRxiv on August 24, 2024, entitled, “The Hemopurifier® Removes Extracellular Vesicles and microRNAs From Renal Perfusates Following Controlled Oxygenated Rewarming of Discarded Donor Kidneys.”
Aethlon Medical’s Hemopurifier® is a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids, qualities which have potential applications in oncology and infectious diseases, as well as in the organ transplant setting.
Renal Perfusate Hemopurifier® Circuit Set-Up
This figure depicts the benchtop configuration of the circuit used to treat the kidney perfusates with the Hemopurifier cartridge. Kidney perfusates were circulated through the Hemopurifier where they passed through a packed column of GNA affinity resin for a total of 24 cycles (30 min). Perfusate samples were collected after treatment and compared to pretreatment samples to identify differences in EV and miRNA contents.
“Kidney transplantation provides the highest quality of life for those afflicted with end stage renal disease, yet a significant shortage in the number of donor kidneys currently exists,” stated Steven LaRosa, MD, Senior Author of the paper and Chief Medical Officer of Aethlon Medical. “To bridge the gap between recipients and donors, the criteria for the use of kidneys from deceased brain death and diseased circulatory death donors has been extended. However, kidneys from extended criteria donors are associated with higher rates of poor graft function and acute rejection in recipients. The release of extracellular vesicles (EVs) and microRNAs from the donor kidney are hypothesized to play a role in these complications and are targets for the, Hemopurifier®.”
Given that one approach to lessen these complications and potentially increase the time of assessment of organ viability is to use machine perfusion on recovered kidneys, and, based on Aethlon Medical’s prior data in COVID-19 and oncology, it was hypothesized that the Hemopurifier® could remove EVs and microRNAs from renal perfusates. In this proof-of-concept study, the company obtained four perfusates from discarded donor kidneys that had undergone a type of machine perfusion called Controlled Oxygenated Rewarming (COR). These perfusates were then pumped over the Hemopurifier® and analyzed for EV counts and microRNA levels. The results confirmed the removal of both small and larger size EVs and a significant reduction in microRNAs.
“While our primary focus is to conduct our planned clinical trials of the Hemopurifier® in India and Australia, in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy, the data generated by this proof-of-concept study is encouraging and provides evidence for adding the transplant indication to our product pipeline,” added James Frakes, Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical. “Next steps to consider would be an additional pre-clinical study comparing mediator removal, renal function and histopathology in a machine perfusion circuit performed both with and without incorporation of the Hemopurifier® on discarded kidneys. Ultimately, a clinical trial designed to demonstrate that incorporation of the Hemopurifier® into renal perfusion improves important clinical endpoints in transplant recipients such as delayed graft function, graft survival or rejection rates would likely be required.”
Source – PR Newswire
