Wyss Institute awarded DARPA contract to further advance sepsis therapeutic device
March 25th, 2013 in Medical research
The microfluidic "Spleen-on-a-chip" developed at the Wyss Institute at Harvard University will be used to rapidly treat bloodstream infections. Credit: Wyss Institute, Harvard University
The Wyss Institute for Biologically Inspired Engineering at Harvard University announced today that it was awarded a $9.25 million contract from the Defense Advanced Research Projects Agency (DARPA) to further advance a blood-cleansing technology developed at the Institute with prior DARPA support, and help accelerate its translation to humans as a new type of sepsis therapy.
The device will be used to treat bloodstream infections that are the leading cause of death in critically ill patients and soldiers injured in combat.
This image shows the microfluidic "Spleen-on-a-chip" developed at the Wyss Institute at Harvard University. Credit: Wyss Institute, Harvard University
To rapidly cleanse the blood of pathogens, the patient's blood is mixed with magnetic nanobeads coated with a genetically engineered version of a human blood 'opsonin' protein that binds to a wide variety of bacteria, fungi, viruses, parasites, and toxins. It is then flowed through microchannels in the device where magnetic forces pull out the bead-bound pathogens without removing human blood cells, proteins, fluids, or electrolytes – much like a human spleen does. The cleansed blood then flows back to the patient.
"In just a few years we have been able to develop a suite of new technologies, and to integrate them to create a powerful new device that could potentially transform the way we treat sepsis," said Wyss founding director and project leader, Don Ingber, M.D., Ph.D. "The continued support from DARPA enables us to advance our device manufacturing capabilities and to obtain validation in large animal models, which is precisely what is required to enable this technology to be moved towards testing in humans."
The team will work to develop manufacturing and integration strategies for its core pathogen-binding opsonin and Spleen-on-a-Chip fluidic separation technologies, as well as a novel coating technology called "SLIPS," which is a super-hydrophobic coating inspired from the slippery surface of a pitcher plant that repels nearly any material it contacts. By coating the inner surface of the channels of the device with SLIPS, blood cleansing can be carried out without the need for anticoagulants to prevent blood clotting.
In addition to Ingber, the multidisciplinary team behind this effort includes Wyss core faculty and Harvard School of Engineering and Applied Science faculty member Joanna Aizenberg, Ph.D., who developed the SLIPS technology; Wyss senior staff member Michael Super, PhD., who engineered the human opsonin protein; and Mark Puder, M.D., Ph.D., Associate Professor of Pediatric Surgery at Boston Children's Hospital and Harvard Medical School who will be assisting with animal studies.
So, where does this leave AEMD? How many others in this business? How many have chance at success. Still not certain that this is NOTa sham company, bases on their lack of success! I've been following AEMD for 6 years, and they seem to offer little more than promises. All this talk about "medical tourism" in India, where is the cash flow back to AEMD? Sorry, but I am very disappointing with this lack of progress!
godfreydaniel35, hemopure36 hooseerfan, you guys have been here for a while, don't lose sight of the IDE, also teaming up with battelle, positive indications, you knew this was a long road when you first bought, FDA expected next two weeks. Hold on for the ride to higher.
It seems that with this technology something has to be added to the blood. I wonder if this device is more compact than the Adapt system even though we do have a portable pump and do not need to add anything to the blood that could cause reactions, contamination ect...?
There are some details to the Wyss approach that may cause problems if they were to ever seek FDA approval...their solution is a bead that is coated with a genetically engineered protein. That would probably be considered a combination product by FDA, but that combination is only part of the solution. After the coated beads attach themselves to the target cells, they must be removed by a magnetic filter.
In a regulatory environment where FDA challenged AEMD to show that the reduction in viral load that was observed in per-clinical trials correlated with cells collected in the HP filter (implying that the cells were removed but not through the actions of the HP???) the bar may be rather high for a combination product/medical device to acquire FDA approval without taking significant time. AEMD was in that position some years back (2008?).
Hey they could be on another path to the same location? Wyss being associated with Harverd Med School and Harvard School of Engineering has vast resources. I went to their website and I would not bet against them that's for sure.