The main role of the kidneys is to filter and eliminate waste, fluid, and minerals from the blood by producing urine. When the two bean-shaped organs lose this ability, waste and fluids accumulate in the body and thus elevate blood pressure levels and lead to kidney failure.
When the kidneys have lost about 90% of their ability to function, one experiences end-stage renal disease.
Nearly 750,000 Americans and around two million people worldwide are being treated for end-stage renal disease (ESRD) and are facing the challenge to find a kidney for transplant.
A national network, The Kidney Project, led by Shuvo Roy of the UCSF Schools of Pharmacy and Medicine, and Vanderbilt University Medical Center nephrologist William H. Fissell, MD.
The team is working hard to develop an implantable bio-artificial kidney that could eliminate the need for dialysis and ease the shortage of donor kidneys.
In November 2019, the team announced that UC San Francisco scientists managed to implant a prototype kidney bioreactor, about the size of a deck of cards, containing functional human kidney cells, into pigs without harming the test subjects and causing an immune reaction or blood clotting.
According to the Roy, this was a key milestone in the development of the technology:
“This is the first demonstration that kidney cells can be implanted successfully in a large animal without immunosuppression and remain healthy enough to perform their function. This is a key milestone for us. 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.”
The Kidney Project develops a device that has a hemofilter, or a blood filtration system that eliminates toxins by passing it through silicon membranes.
Moreover, it has a bioreactor, with cultured human kidney cells that act like an actual human kidney. To test the safety of the hemofiltration system, the team is currently waiting for the FDA to approve a clinical trial.
Fissell explains that the procedure will be similar to kidney transplant surgery and will be performed under general anesthesia.
When the bioartificial kidney device will be available publicly, the procedure can be performed at any hospital with a trained transplant surgical team.
The bioartificial kidney is also expected to save national health care dollars, because, as Roy explains, “medicare currently covers dialysis for life, but immunosuppressive drugs are covered for just the first three years following transplant. “
Fissell adds that the project is a hybrid between present and future:
“Right now, the only thing we can offer kidney failure patients is 40-year-old dialysis technology that’s imperfect. In 15 years, we’ve moved from answering science questions to developing engineering solutions that don’t require blood thinners, immunosuppressants, pumps, and wires. We just need cash to implement it, and we’re working as hard and as fast as we can. A patient’s well-being shouldn’t be held hostage to an uncertain calendar of discovery science.”
Roy estimates that they have a long way to go, even though they are progressing:
“Advancing a complex cell therapy like this into the clinic will not be a trivial task — for instance, it will require substantial investments in cell production and characterization in controlled GMP facilities to avoid any possibility of contamination. Now we’ve confirmed that we’re on the right track to move forward with these efforts.”