Artificial Kidneys May Start Saving Lives Soon

artificial kidney, breaking medical device newsShuvo Roy, PhD, holds a prototype of a surgically implantable, artificial kidney, a promising alternative to kidney transplantation or dialysis for people with end-stage kidney disease. Photo by Susan Merrell

Those waiting in a long line for a kidney donation might soon find themselves moving forward faster than expected. Scientists are making progress on a new surgically implantable, artificial kidney. The new technology is designed to be an alternative to a kidney transplant or dialysis, and completely mimics the functions of a kidney inside the body.

The first in line will be patients suffering from permanent kidney failure, known as End Stage Renal Disease, or ESRD. Affecting 2 million people worldwide, ESRD is fatal unless treated and costs the nation almost $40 billion each year for treatment. Unfortunately the main treatment is kidney dialysis, a short-term and costly option. Transplantation is the most effective treatment option, but donor organs are in short supply.

“We can provide an alternative therapy and a treatment option that doesn’t exist today for the vast majority of people today that are forced to rely on dialysis,” said Shuvo Roy, PhD, a bioengineer on the faculty of the UCSF School of Pharmacy and the project’s technical director

The artificial kidney was developed with a silicon nanofilter that can remove salts, toxins, water and some small molecules from the blood. The silicon nanofilter works on blood pressure alone, without the aid of a pump or electrical power. Its design was inspired by the manufacturing methods for the production of semiconductor electronics and microelectromechanical systems. Researchers believe that the nanofilters could deliver more benefits  such as more uniform pore size compared to filters being used in dialysis machines.

Researchers have already created a prototype of the artificial kidney and started conducting tests on the coffee cup-sized device. The device will be connected internally to the blood supply of the patients and to their bladder , and it would be implanted near the kidneys, which will not be removed.

“We aim to conduct clinical trials on an implantable, engineered organ in this decade, and we are coordinating our efforts with both the NIH and the U.S. Food and Drug Administration,” Roy said in a press release.

Artificial Kidneys Fast-Tracked by FDA

Last year, the artificial kidney project was selected as one of the first projects to undergo more timely and collaborative review at the Food and Drug Administration (FDA). The FDA chose three renal device projects to pilot a new regulatory approval program called Innovation Pathway 2.0, intended to bring breakthrough medical device technologies to patients faster and more efficiently.

The artificial kidney project, which is targeted for clinical trials in 2017, was selected for its transformative potential in treating ESRD and for its potential to benefit from early interactions with the FDA in the approval process.

The UCSF artificial kidney, or implantable Renal Assist Device (iRAD) would include thousands of microscopic filters as well as a bioreactor to mimic the metabolic and water-balancing roles of a real kidney.

The combined treatment has been proven to work for the sickest patients using a room-sized external model developed by a team member at the University of Michigan. Roy’s goal is to apply silicon fabrication technology, along with specially engineered compartments for live kidney cells, to shrink that large-scale technology into a device the size of a coffee cup. The device would then be implanted in the body, allowing the patient to live a more normal life.

Kidney Failure a Growing Problem in the U.S.

In part because the U.S. population has grown older and heavier and is more likely to develop high blood pressure and diabetes, conditions often associated with kidney failure, the number of individuals diagnosed with kidney failure is growing. It has risen 57 percent since 2000, according to the National Kidney Foundation. More than 615,000 people now are being treated for kidney failure. U.S. government statistics indicate that kidney failure costs the U.S. healthcare system $40 billion annually and accounts for more than six percent of Medicare spending.

The waiting list for kidney transplants in the United States has grown to more than 100,000 people. The number of available kidneys has remained stagnant for the past decade, and only about one in five now on the list is expected to receive a transplant.

More than 430,000 of those with kidney failure now undergo dialysis, which is more costly and less effective than transplantation and typically requires hours-long stays at a clinic, three times weekly. Only about one in three patients who begins dialysis survives longer than five years, in comparison to more than four in five transplant recipients.

Fissell, associate professor in the Department of Medicine at Vanderbilt and medical director for The Kidney Project, said, “This project is about creating a permanent solution to the scarcity problem in organ transplantation. We are increasing the options for people with chronic kidney disease who would otherwise be forced onto dialysis.”

Along with Roy at UCSF and Fissell at Vanderbilt, a national team of scientists and engineers at universities and small businesses are working toward making the implantable artificial kidney available to patients.

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