by Kelsey Herbers
A $500,000 KidneyX prize has been awarded to The Kidney Project — a collaboration between Vanderbilt University Medical Center and University of California, San Francisco (UCSF) — for the development of an implantable dialysis system that would enable patients to safely and effectively treat kidney failure at home.
The proposed system, called iHemo, involves connecting an implanted hemofilter-like device to a patient’s circulatory system within their abdomen, then using an external pump to infuse blood cleansing “dialysate” through the device to filter out blood toxins. This allows patients to perform frequent and prolonged treatments in a safe and simple manner at home.
Hemodialysis is the current standard of care for more than half a million patients with kidney failure in the United States, and the number of Americans in need of dialysis increases every year. Three weekly visits to a dialysis center can extend a patient’s life while they endure the long wait for rare kidney transplants, but the half-century-old technique is both inefficient and expensive, estimated to account for about 7% of Medicare’s annual budget.
“Home dialysis has many advantages, but patients are put off by the equipment and the fear of needles and accidental bleeding,” said William Fissell, MD, associate professor of Medicine in the Division of Nephrology at VUMC, who leads The Kidney Project alongside UCSF’s Shuvo Roy, PhD.
“We’re going to provide the ability for patients to perform their own dialysis sessions at home at their convenience according to their schedules. By eliminating the blood, needles and drain bags, we hope to get past the fear factor and reduce the footprint of the machinery.”
KidneyX is a public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology to “accelerate innovation in the prevention, diagnosis and treatment of kidney diseases.” The Kidney Project team was among 15 winners of the KidneyX: Redesign Dialysis Phase 1 competition in 2019 and is now one of six winning teams in the competition’s second phase.
In addition to the financial prize, the winning teams will work closely with leadership of the U.S. Food and Drug Administration, Medicare and HHS to accelerate the translation of their concept into a patient-ready device.
For the past decade, Fissell and Roy’s collaboration has been working on a fully functional implantable bioartificial kidney with the goal of eliminating the need for dialysis altogether. The two-part device consists of the iHemo “hemofilter” and a “bioreactor” containing living kidney cells to perform other key kidney functions, such as maintaining blood pH and hydration.
The full artificial kidney is still some years away from being approved for clinical use, but the device’s hemofilter component can be adapted into an implantable dialysis system for home use.
“Our ultimate goal continues to be the elimination of dialysis by developing a fully functional, implantable artificial kidney,” said Roy. “By catalyzing the development of iHemo, the KidneyX prize will allow us to adapt our technology quickly for simple and safe dialysis treatment at home.”
Since winning a KidneyX Phase 1 prize in 2019, the research team has developed a prototype device and shown that its advanced nanofabricated materials can effectively filter blood in healthy pigs for up to 30 days without producing blood clots.
The KidneyX Phase 2 prize will allow the team to scale up the device to handle the blood volume needed for a clinically useful device in human kidney patients and to demonstrate its ability to effectively treat pigs with kidney failure.
