FRANCISCO — No matter what else is happening in his life,
David Anderson knows he cannot go far from the dialysis
machine that sustains him.
vacations, get-togethers with friends — everything takes a
back seat to his thrice-weekly treatments that do the work of
his failing kidneys.
across town, University of California-San Francisco
researchers are using Silicon Valley technology to create a
device they hope can untether the 63-year-old San Franciscan
and 380,000 other Americans who rely on dialysis to cope with
developing an implantable, artificial kidney that would shrink
the refrigerator-size dialysis machine into a device the size
of a coffee cup and perform functions a dialysis machine
who has been on dialysis more than five years. said he would
gladly be the first test case. "I wouldn’t hesitate for
a second," he said. "It’s just amazing. You want
to live long enough to see some of this in place."
device has shown such promise that the U.S. Food and Drug
Administration last year selected it as one of three projects
for a special fast-track approval process. Researchers hope it
will be ready for human trials in 2017.
realized we could achieve a dialysis filter that would be
one-twentieth the size of what’s commercially available, and
would require so little power that we could drive it just off
blood pressure alone," said Shuvo Roy, a UCSF associate
professor of bioengineering and therapeutic sciences.
Researchers are using silicon nanotechnology to design the
leading a team of 40 scientists working on the project at nine
institutions around the country.
believes the device has the potential to save the federal
Medicare program millions of dollars.
room-size, external model of the technique was shown to work
for very sick patients at the University of Michigan.
than 600,000 Americans, and nearly 2 million people worldwide,
have end-stage renal disease, the complete or nearly complete
failure of kidneys.
decades, little has changed in the treatments available, even
though the number of patients is rising by 5 percent a year,
mainly because of growing rates of diabetes and high blood
option for those with failing kidneys is a kidney transplant.
But not nearly enough organs are available. With more than
95,000 people on a waiting list, and about 18,000 kidney
transplants each year, most people are left out.
nearly 5,000 people died while awaiting kidney transplants.
leaves dialysis to help keep people alive until a transplant
becomes available. But it is a less-than-ideal solution.
Anderson misses even one of his 3 ½-hour sessions, his body
lets him know. His diseased kidneys allow toxins, waste and
fluids to accumulate, a risky condition that makes him feel
bloated and terrible.
blood pressure goes up; it’s a dangerous business," he
people who undergo dialysis have other health issues,
including heart and circulation problems, notes Dr. Lynda
Frassetto, a UCSF professor of medicine.
just barely doing OK," Frassetto said. "You have to
follow a very strict diet. You have to be careful about the
fluid you take in."
artificial kidney, blood brought into one side of the device
passes through a silicon filter that removes toxins, sugars,
salts and water, creating an "ultrafiltrate," Roy
filtrate would move to the other side of the device, where
actual kidney cells would reabsorb the water, sugars and salts
back into the bloodstream, mimicking a real kidney’s
metabolic and water-balancing roles in a way that dialysis
cannot. The team obtains the kidney cells from organs rejected
the kidney cells in the device would be separated from the
immune components of a patient’s blood, the researchers
believe it would not trigger a rejection, relieving patients
from the costly necessity of immune-suppressing drugs.
noted that kidney disease takes a huge bite out of the nation’s
health care budget. Medicare covers the cost of dialysis for
many people, and it is a hefty expense: $82,000 or more
annually per patient. A kidney transplant surgery runs $50,000
told, end-stage kidney disease costs Medicare $33 billion per
hopes an artificial kidney could be manufactured for $30,000
or less. Testing in animals could begin by about 2016, but it
would probably be 2020 or later before the device, if proved
effective, could become a routine therapy.
April, the FDA selected the artificial kidney for its
Innovation Pathway, a pilot program to help medical devices
reach patients faster, while ensuring their safety.
cost about $20 million to develop the artificial kidney and
take it through its first clinical trial, Roy estimated. So
far, the team has grants and gifts of about $7 million.
has been watching the developments with excitement. He has
been undergoing dialysis since December 2007 — his second
stint on the treatment. Before that, he had a transplanted
kidney that lasted four years until it failed.
has toured Roy’s lab and is eager to see what changes may
really a cutting-edge project," he said. "You
realize just what a complicated thing they’re putting
together. You think: Why can’t I get this tomorrow?"
and Drug Administration last year selected three projects for
its Innovation Pathway program to streamline approval and get
breakthrough treatments to patients faster:
implantable, artificial kidney being designed at UC San
Francisco and eight other institutions.
wearable artificial kidney in development by Blood
Purification Technologies of Beverly Hills.
special valve designed by CreatiVasc Medical of Greenville,
S.C., to make blood vessel access safer during dialysis.