Shuvo Roy, PhD, a professor in the Department of Bioengineering and Therapeutic Sciences, is leading the drive to develop an implantable bioartificial kidney, an innovative device that would spare kidney patients from dialysis and transplant wait lists. 

His team’s research journey on The Kidney Project has overcome significant pandemic setbacks and reinvented its operations, sparking new innovations with promise for a range of therapeutic applications, including transfusion medicine, neonatal care, and diabetes treatment. 

We spoke with Roy about how his lab has evolved and where his research is headed next. 

Q: The artificial kidney has been the centerpiece of your lab for many years. Tell us about this project.

The latest breakthrough in the field of renal failure is pig kidney transplants, but patients face risks from the high levels of immunosuppressive medicine required for them to fight off rejection and infection. Our device, in which our silicon filter technology keeps the kidney cells separate from the patient, will avoid the need for immunosuppression altogether. Another concern is zoonotic virus transmission from the pigs. Again, the membrane serves as a barrier, so there is no risk of viruses crossing into the patient's bloodstream. 

We’re not aiming to replicate the full complexity of a healthy kidney, at least not initially. Instead, we’re focused on providing the main functions that will keep a patient off dialysis and allow them to have a better quality of life. 

Stage 4 of chronic kidney disease (CKD) can generally be managed with medication and lifestyle changes. Stage 5 is kidney failure, and unless the patient gets a transplant, dialysis is required to avoid death. With dialysis, the number of morbidities and rates of complications drastically increase. So our approach, for the initial device, is to provide enough function to get patients back to the health level of Stage 3 or Stage 4 CKD patients. From there, we can add more functionality and get them back to even better health. We’ve been able to show that our device actually works by successfully generating urine in the lab. 

Q: What challenges have you faced, and where does this project stand today?

A: Before the pandemic, we were right at the point of doing the preclinical studies that would launch our first clinical study, but the shutdown forced us to halt. With limited access to facilities, severe material shortages, and departures of key personnel, we lost a lot of momentum and resources. It was difficult to construct prototypes and complete the preclinical testing needed to gather data to submit to the Food and Drug Administration (FDA). By the time we came out of the pandemic, it was clear that we would have to take steps back and redo some of the critical experiments.  

Over the past 18 months, I’ve focused on rebuilding the research program from the ground up. We’ve now re-established the core team, focused on revalidating the science, and demonstrated proof-of-concept by generating urine in the lab. The next step is securing sufficient funding and FDA alignment for early feasibility studies in patients. It has been a long road, but thanks to our team, and collaborators both at UCSF and across the country, we are moving forward again. 

Q: How has this kidney research inspired other projects?

My foundational training is as an electrical engineer and applied physicist, specializing in sensor technology. Much of my work outside The Kidney Project involves collaboration with colleagues in the UCSF Department of Surgery — specifically with pediatric surgeons, partly thanks to a joint FDA-funded grant to help accelerate device development for pediatrics. This has led to a collaborative program we call “Surgical Innovations,” which brings together surgeon trainees with bioengineering graduate students and postdocs. 

One effort that came out of this collaboration was a project in transfusion medicine, funded by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). We had a UCSF resident surgeon work with bioengineers in our lab to investigate whether we could deactivate or remove viruses and bacteria in blood before it’s given to the recipient. That technology leverages the same core silicon membrane filter technology we developed for use in the bioartificial kidney. 

Another spinoff from The Kidney Project and the pediatric specialists at UCSF uses this same filter technology for Extra Corporeal Membrane Oxygenation (ECMO). During the pandemic, many patients with severe respiratory distress were put on ventilators, which often led to serious complications. ECMO, which filters blood and pushes oxygen into it like a lung, was a more efficacious treatment, though a complicated alternative.  

A clinical fellow in my lab saw an opportunity to simplify ECMO for a vulnerable population: pre-term babies with underdeveloped lungs. Crucially, we had demonstrated for the artificial kidney application that no blood thinners are needed, and this feature would be a major advantage for ECMO. This work has led to two grants to advance the development of the membrane oxygenator for neonatal applications, and ultimately, an “artificial placenta.” 

Q: Your lab has also explored an artificial pancreas. How did that project come about?

That idea also grew out of The Kidney Project. During our animal studies, a surgical colleague suggested that the same filter technology for the artificial kidney could be adapted to protect insulin-producing cells. Diabetes is the leading cause of kidney failure, so there’s a natural connection between the two diseases. It made sense to ask whether we could design a bioartificial pancreas to deliver insulin, without the need for daily injections or immunosuppression.  

Over the past few years, we collaborated with colleagues all across UCSF: bioengineering colleagues within the School of Pharmacy, stem cell experts from the Broad Center of Regeneration Medicine and Stem Cell Research, transplant immunologists and surgeons in the UCSF Division of Transplant Surgery, and beta cell experts in the Diabetes Center at UCSF. With funding from the Juvenile Diabetes Research Foundation and the California Institute of Regenerative Medicine, as well as a grant from the National Institutes of Health, we advanced the work from an abstract concept to working prototypes that successfully treated diabetes in pigs.  

Q: Why is collaboration so important to your lab?

What I do is translational bioengineering, and, by its very nature, it has to be a team effort. Here at UCSF, both in the School of Pharmacy and beyond, I’m fortunate to have some of the brightest and hardest-working colleagues all focused on our mission of advancing health. There are tremendous discoveries coming out of basic science labs, and clinicians are at the forefront of treating a wide range of disease conditions. I feel privileged that I can find opportunities to bring my engineering toolkit to connect the discoveries with clinical needs.