A biomedical tool that tricks aggressive brain tumours into migrating to an external container rather than in the brain has been designated a “breakthrough device” by the FDA.
The device mimics the physical properties of the brain’s white matter to entice aggressive tumours to migrate toward the exterior of the brain, where the migrating cells can be collected and removed. The purpose of the device is not to halt its lethal spread, making the disease easier to manage.
The device works by mimicking the physical structures of the brain’s white matter where it travels through a narrow opening connecting the left and right hemispheres, which is a popular growth track for glioblastoma. There are no chemicals or enzymes involved, and there are a wide variety of materials that the device could be made from.
Because the material itself isn’t as important as its physical structure, the researchers have swapped a material into their design known to last a long time and be well tolerated by the human body. In its current iteration, the device resembles a long, thin catheter tube with a small reservoir at the end that sits on top of the skull under the scalp. The researchers have also removed the toxic gel contained in the reservoir to simplify FDA approval.
“What’s most important is that the tumour is spreading in a controlled way through our device to a reservoir, and away from the mother tumour, rather than through the healthy brain tissue,” said Nassir Mokarram, research lead from Duke University. “The toxic gel inside the reservoir appears to only play a secondary role, though additional preclinical studies will help make this clear. Simply by being far away from the mother tumour, the cells are more susceptible to dying anyway, and a neurosurgeon can access the reservoir to empty it when needed.”
The researchers are now working to demonstrate the device is safe for human trials, a task that is easier said than done.
“The most exciting part about this designation is that it gives us the opportunity to look at the FDA as a partner rather than a reviewer,” Mokarram continued. “The task before us is to prove that the device does not pose a risk to human patients, which is an extremely complicated process. With direct access to the FDA reviewers, we can get more efficient, faster feedback on our experimental ideas to make sure we’re addressing all of their concerns from the very start.”
With the help of the FDA, the research group hopes to solidify their experimental plans within the next several weeks. They are working toward gaining FDA approval for human trials by the end of 2019.