Outside of dialysis and transplantations, implantable artificial kidneys present an additional option for treating kidney disease, according to an expert.
In a discussion with Pharmacy Times, Shuvo Roy, PhD, bioengineer and professor at the University of California, San Francisco in the department of bioengineering and therapeutic sciences and UCFS schools of pharmacy and medicine, discusses the current state of wearable and implantable bioartificial kidneys, the technologies used to achieve these advancements, and what research in the area will look like in the future. Roy will be presenting at the panel “The Wearable or Implantable Bioartificial Kidney in 2023 and Beyond” during ASN Kidney Week in Philadelphia, Pennsylvania (November 2, 2023, to November 5, 2023).
Pharmacy Times: Can you provide an overview of the current state of wearable and implantable bioartificial kidneys in 2023, and what key advancements have been made in this field?
Shuvo Roy: So, implantable artificial kidneys are, fundamentally, coming about because there's a tremendous need. And the tremendous need is that there’s just not enough donor organs available for transplant, and most of the patients have to rely on dialysis, which is fraught with complications and poor survival outcomes. …Except for pancreatic and lung cancer, dialysis patients have worse survival than all cancer patients. So clearly, it's a disease with poor outcomes, poor quality of life. The best treatment is a kidney transplant, but there’s just not enough organs available, so there's a need to provide a therapy that provides renal replacement that's comparable to a transplant. And that's what implantable artificial kidneys are aiming to do. You can make artificial kidneys, wearable or implantable. The vast majority of work has proceeded on making devices that function as artificial kidneys.
Pharmacy Times: What technologies are being utilized to achieve these advancements?
Roy: In the field of artificial kidneys, there are people working on xenogeneic implants, meaning pig kidneys for humans. Then the [next] approach we are taking is [with] a hybrid device that combines kidney cells with mechanical filtration. So, the people working with pig kidneys, the technology they are using is gene editing the pig kidneys, so they will not be rejected by the human body.
For us, we are combining semiconductor silicon filtration units with kidney cells inside the device that provide the metabolic functions of the kidney. So, the 2 groups are gene-editing of pig kidneys for xenogeneic implants, and then we're using semiconductors, silicon manufacturing technology to make something that is small, smart, and cost-effective that does not require immune suppression drugs, because the kidney cells we have in our device are protected from the patient's immune system.
Pharmacy Times: How are wearable and artificial kidneys advancing this year in terms of functionality, efficiency and patient comfort compared to previous iterations?
Roy: There is no product that's on the market yet, everybody is at different stages of preclinical testing. So, the pig kidneys…have been tested on [patients who have brain death] and they have shown that the implanted pig kidneys can function for some time. We have built small-scale prototypes of our biohybrid kidneys and tested them in pigs to create urine. So, compared to years past, we are actually [making progress in] both types of efforts and animal studies, and we are beyond the fundamental proof of concept on the scientific side. That was not the case 5 years ago.
Pharmacy Times: In terms of treatment, is there anything that pharmacists may need to know about artificial kidneys?
Roy: Yes, the different types of artificial kidneys will require different regimens of medication. The approach our lab is taking [does not involve] immunosuppressant drugs whatsoever. For pig kidneys as intergenic transplants, they are likely going to need some level of immunosuppression. So, as we get more information for how well these artificial kidneys work, it will influence the medications that are needed by the patient and pharmacists should be aware of how these devices are functioning, because it will influence how they may treat their patients.
Pharmacy Times: What are the key areas of development or research in this field that you anticipate will shape the landscape beyond 2023?
Roy: I think we'll get a lot more insights in manufacturing methodologies for the artificial kidneys, in safety and assessment of the xenogeneic kidneys. Both of these fields will flourish based on the learnings we get this year and beyond. It's exciting that the American Society of Nephrology is highlighting the development in artificial kidneys. The field of kidney disease is now moving at a faster pace [because there is] recognition that something must be done for this group of patients that have had kidney failure. [They] have been underserved for so long.