FDA may soon approve UCSF kidney device

June 18, 2012 5:51:16 PM PDT
A biotech project is in the works that could change the lives of thousands of kidney patients. The Food and Drug Administration is now helping to fast track an artificial kidney device being developed by researchers at UCSF.

With a failed kidney transplant now behind him, David Anderson has settled into a routine of regular dialysis and the limitations that go with it.

"If you skip one of those sessions, generally speaking, you know it. You don't feel well," said Anderson.

But soon, a technology being developed here in the Bay Area, could free patients like Anderson from the stationary machine.

Researchers at UCSF are refining designs for an artificial kidney. An implantable device designed to filter the blood and perform all the functions of the human kidney.

"We try to mimic a number of those functions by a combination of mechanical component, which is silicon filters that we have developed, and combine that with cells that we've harvested from human kidneys," said Shuvo Roy, Ph.D., the project director from UCSF.

Roy says the silicon filters are microscopic, containing millions of tiny pores to purify the blood.

"These are pores that are so tiny, they let only water and salt through, but do not let any proteins through," said Roy.

After it's purified, the blood flows through a second chamber, called a bio-reactor, where it reacts with living kidney cells. Roy says those cells perform many of the same functions as a healthy kidney, including regulating blood pressure and producing Vitamin D.

"As we refine the prototypes, as we learn more from our testing, it's definitely conceivable that this would actually be an end goal in itself because there simply aren't enough transplants to go around," said Roy.

The UCSF team just received a major boost from the FDA. The artificial kidney is one of just three projects selected for a pilot program that will fast track the development of breakthrough medical devices.

The agency will now work with the team as it improves the system, meaning it could ultimately be cleared for clinical trials much more quickly.

"The filtration component of our device, we've got that down. And I think you're going to see that device move towards human testing in the next couple of years," said Roy.

And if that day comes, the team will have at least one volunteer ready to go. Anderson receives his dialysis at UCSF and says given the chance, he'd be first in line for an implant.

"Oh, I would do it immediately. Immediately with no hesitation," said Anderson.


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