Two key contributors to the UCSF-led effort to create an implantable artificial kidney for dialysis patients are on Capitol Hill today to inform key congressional staff about the project.
Shuvo Roy, PhD, a bioengineer on the faculty of the UCSF School of Pharmacy and the project's technical director, and William Fissell, MD, an associate professor of clinical medicine at Vanderbilt University Medical Center and the project's medical director, are in Washington, DC, to explain the importance of the device to treat patients with end-stage renal disease (ESRD).
Affecting 2 million people worldwide, ESRD – or chronic kidney failure – is fatal unless treated and costs the nation almost $40 billion each year for treatment. And while transplantation is the most effective treatment option, donor organs are in short supply. Further, kidney dialysis is a short-term and costly treatment.
“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,” Roy said.
The artificial kidney project aims to combine nano-scale engineering with the most recent advances in cellular biology to create an implantable device that would enable patients with chronic kidney failure to lead healthier and more productive lives, without external dialysis or immune suppressant medication.
The kidney project is now featured in the UC Office of the President's Onward California campaign, which aims to educate Californians about the impact the University has in their lives and to remind them of the importance of supporting the UC system.
Kidney Project Put on Fast-Track 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.
UCSF University Relations writers Lisa Cisneros and Kristen Bole contributed to this report.