Aethlon Medical's Hemopurifier Shows Promise for Long COVID Treatment in Preclinical Study
核心洞察
Aethlon Medical published preclinical data showing its Hemopurifier (搜索) device successfully removes extracellular vesicles (搜索) from Long COVID (搜索) patient plasma samples and reduces inflammatory microRNAs.
The study found significantly elevated mannose-positive extracellular vesicles (搜索) in Long COVID (搜索) patients compared to recovered controls, providing a potential therapeutic target.
The device's GNA (搜索) affinity resin depleted seven microRNAs associated with inflammatory pathways, including JAK-STAT (搜索), which is currently being targeted in Long COVID (搜索) clinical trials.
Aethlon Medical announced the publication of preclinical data demonstrating that its investigational Hemopurifier (搜索) device can remove harmful extracellular vesicles (搜索) from Long COVID (搜索) patient samples and reduce inflammatory microRNAs. The study, published November 20, 2025, in the preprint archive bioRxiv, represents the first evidence that the device's proprietary technology may offer therapeutic potential for Long COVID patients.
Addressing an Unmet Medical Need
Long COVID (搜索) affects an estimated 44 to 48 million people in the United States alone, with a projected economic burden of $2 billion for those experiencing symptoms lasting a year. Despite over $1 billion allocated to Long COVID research funding, no treatment has proven effective for the persistent symptoms that include fatigue, post-exertional malaise, shortness of breath, chest pain, and cognitive difficulties such as "brain fog."
Targeting Extracellular Vesicles
The study focused on extracellular vesicles (搜索) (EVs), nanoparticles 50-500nm in diameter released from all cell types that are involved in cell-to-cell communication and have been implicated in Long COVID (搜索) pathogenesis. These vesicles contain viral particles and microRNA (搜索) molecules that regulate protein production and have been associated with abnormal blood clotting and inflammation.
Aethlon Medical collaborated with the University of California San Francisco Medical Center (搜索) Long COVID (搜索) clinic to evaluate plasma samples from Long COVID participants and control participants who had recovered from COVID-19 (搜索). The research team isolated both large (100-500 nm) and small (40-200 nm) EVs from plasma samples to assess their binding to Galanthus nivalis agglutinin (搜索) (GNA (搜索)) and removal by the GNA affinity resin.
Key Findings
The study revealed that plasma from Long COVID (搜索) patients contained elevated levels of both large and small EVs. Significantly, mannose-positive large EVs were substantially increased in Long COVID patient samples compared to recovered controls. The removal of small EVs by the GNA (搜索) affinity resin correlated with mannose-positive large EVs, indicating the same glycan target for removal was present in both populations.
NanoString analyses identified seven EV-associated microRNAs that were significantly depleted by GNA (搜索) affinity resin treatment of plasma. Pathway activity interference software analysis suggested that removal of these microRNAs may be associated with downregulation of inflammatory pathways, including JAK-STAT (搜索), and upregulation of tissue repair pathways.
Clinical Implications
"The data from this ex vivo study is exciting because it demonstrated for the first time that the GNA (搜索) affinity resin in our device removes extracellular vesicles (搜索) in Long COVID (搜索) patient samples and removes microRNAs associated with the JAK-STAT (搜索) pathway which is a therapeutic target in current Long COVID clinical trials," said Steven P. LaRosa, MD, Chief Medical Officer at Aethlon Medical and senior author on the paper.
The JAK-STAT (搜索) pathway connection is particularly significant as this pathway is already being investigated as a therapeutic target in ongoing Long COVID (搜索) clinical trials, potentially validating the Hemopurifier (搜索)'s mechanism of action.
Device Technology and Regulatory Status
The Hemopurifier (搜索) is an investigational extracorporeal device designed to bind and remove harmful EVs from blood through plasma separation, size exclusion, and binding to a proprietary affinity resin containing the plant lectin GNA (搜索), which binds to the sugar mannose. The device has previously demonstrated the ability to remove EVs and decrease microRNAs in a patient with severe acute COVID-19 (搜索) infection.
The Hemopurifier (搜索) holds FDA Breakthrough Device designation for treating individuals with advanced or metastatic cancer (搜索) who are unresponsive to or intolerant of standard care therapy. It also maintains a separate FDA Breakthrough Device designation and an open Investigational Device Exemption application for treating life-threatening viruses not addressed by approved therapies.
Future Research Directions
LaRosa indicated that the company plans to expand this research by examining whether EV removal decreases SARS-CoV-2 (搜索) viral particles, as viral persistence is considered an important pathogenic mechanism in Long COVID (搜索). James Frakes, Chief Executive Officer at Aethlon, noted that while oncology remains the lead clinical indication, this preclinical data provides additional evidence that EV removal has therapeutic potential beyond cancer (搜索) applications.
The company describes the Hemopurifier (搜索) as "a pipeline within a single device," reflecting its potential applications across multiple disease areas where extracellular vesicles (搜索) play a pathogenic role.