Note: Shuvo Roy, PhD, is a four-time CTSI Catalyst Program Awardee, for different applications of his silicon membrane technology including for the kidney, artificial pancreas and high efficiency external ambulatory lung. The project team received a Fall 2017 Catalyst Award to collect data on their artificial kidney membrane prototypes and provide sterilization procedures information to the FDA as part of their submission to obtain FDA approval as an IDE to start their clinical studies testing of the silicon nanopore membranes.
By Nicholas Weiler via UCSF School of Pharmacy
The Kidney Project, a national effort to develop an implantable bioartificial kidney that could eliminate the need for dialysis, announced a key milestone in a November 7 presentation at the American Society of Nephrology Kidney Week 2019 conference in Washington, DC.
The project team reported that UC San Francisco scientists successfully implanted a prototype kidney bioreactor containing functional human kidney cells in large animals without significant safety concerns. The device, which is about the size of a deck of cards, did not trigger an immune reaction or cause blood clots, an important milestone on the road to future human trials.
“This is the first demonstration that kidney cells can be implanted successfully without immunosuppression in preclinical models and remain healthy enough to perform their function. This is a key milestone for us on the way to clinical trials in humans,” said Shuvo Roy, PhD, a faculty member in the Department of Bioengineering and Therapeutic Sciences, a joint department of the UCSF Schools of Pharmacy and Medicine. “Based on these results, we can now focus on scaling up the bioreactor and combining it with the blood filtration component of the artificial kidney."
Kidney Project aims to give options to end stage renal disease patients
Nearly 750,000 Americans — and two million people around the world — are treated for end stage renal disease (ESRD). Rates of kidney disease are growing rapidly, leading to an urgent shortage of kidneys for transplant. As of 2016, there were only 21,000 donor kidneys available for transplant in the U.S. on a waiting list of nearly 100,000 and extending five to ten years.
Most patients awaiting a transplant survive by undergoing long and cumbersome dialysis treatments multiple times a week to clear toxins from their blood. Dialysis and other treatments for ESRD, which are universally covered by Medicare, cost $35 billion in 2016, representing seven percent of Medicare’s annual budget, and do not replace essential kidney functions such as regulating blood pressure, maintaining electrolyte balance, or producing hormones.
The Kidney Project is led by Roy and Vanderbilt University Medical Center nephrologist William H. Fissell, MD, who for more than a decade have been working to develop an implantable bioartificial kidney with the goal of eliminating dialysis and offering an option to kidney transplant.
The implantable device being developed by The Kidney Project consists of two components: a blood filtration system called the hemofilter, which removes toxins from the blood by passing it through silicon membranes fabricated with precisely shaped nanometer-scale pores; and a bioreactor, which contains cultured human kidney cells intended to perform other kidney functions, such as maintaining adequate fluid volume and blood pressure, adjusting salt levels, and producing essential hormones.
Following promising preclinical studies, The Kidney Project’s hemofiltration system is currently awaiting FDA approval for an initial clinical trial to evaluate its safety.