Innovations for End-Stage Renal Patients July 23, 2015 by Chelsey Fix As many researchers continue to search for ways to minimize the damage caused by chronic kidney disease, The Kidney Project is exploring an innovative way to improve the lives of patients who have experienced kidney failure. The lab at UCSF is heading a project on a small, implantable artificial kidney, and NephCure had the chance to hold a Q&A with The Kidney Project to hear all about this project. It could be a game-changer for patients in need of dialysis! 1. What interests you about this area of the body? Why did you choose to work with kidneys? Chronic kidney disease has reached epidemic proportions. An astounding 26 million Americans live with this disorder. As incidences of diabetes, high blood pressure, and obesity rise – some of the key causes of chronic kidney disease – so do the numbers of people diagnosed with kidney failure. These patients will either need dialysis or a kidney transplant. Neither option is ideal. Only 20 percent of patients on a kidney transplant wait list in any given year receive a new kidney, and individuals receiving dialysis are often unable to work, eat normally, or live full lives. Our team is developing a surgically implanted, bioartificial kidney to perform the vast majority of the filtration, balancing, and other biological functions of the natural kidney. The two-part device combines a membrane hemofilter and a bioreactor of human renal tubule cells to mimic many of the metabolic, endocrine, and immunological functions of a healthy kidney. It is powered by the body’s own blood pressure without the need for external tubes and tethers or immunosuppressant drugs. 2. Where is the artificial kidney at in the development process? When do you hope to have it available for patients? We need to complete animal studies to demonstrate safety and functionality of the bioartificial kidney. Through our collaboration with the Food and Drug Administration (FDA), we have developed a pathway that will allow us to arrive at the first clinical trials with a pre-negotiated set of milestones. In this pathway, we must first show that the hemofilter will successfully operate in vivo for 30 days. We are currently working on this task. Given our budgetary constraints, we have taken the approach of constructing small-scale hemofilters and evaluating their performance inside animals as a function of filter arrangement, vascular connections, and surface coatings. We have successfully shown filtration for 10 days and vascular patency for 30 days. As funding becomes available, we will increase the filtration to 30 days with full-scale devices. The completion of this key task will provide the necessary data for us to approach the FDA for approval of the first clinical trial. We expect to have a device released for clinical trials in the year 2017 if we successfully raise all of the necessary funding and we do not encounter any unanticipated development challenges. Typically, there are at least two cycles of clinical testing required for all medical devices. The nature of the results of the first round of clinical trials will largely influence the timing of release and industrial-scale manufacturing. That being said, we estimate that the clinical trials will be complete by the year 2020. During the clinical trials, we will be working with manufacturers to discuss and manage the details of production. Once the clinical trials are complete, the device will be immediately available for patients. 3. Is there anything that our patients can do to assist with your efforts? The Kidney Project is an ambitious project and is not without its challenges. In the short term, our primary challenge is funding the research. A significant hurdle is procuring enough money in order to proceed through the preclinical studies, which would allow us to build full-scale prototypes to generate data for the first round of in-human studies. NKI’s note- Eventually, patients will be needed for these studies, so be sure to check our website, and The Kidney Project’s website often to stay up to date! 4. What other innovative projects should we be aware of? What’s exciting about kidney research right now? Several teams have developed the idea behind a wearable artificial kidney (WAK), which translates the traditional dialysis machine into something that can be worn on a belt around the waist. It works by filtering a patient’s blood through a membrane. While it is much more convenient than conventional dialysis, it is does not perform all the functions of a healthy kidney. We are excited about The Kidney Project and the promise it holds for patients. By building on proven scientific successes in cell biology and silicon nanotechnology, we are engineering an implantable and self-regulating bioartificial kidney that does not require the patient to be tethered to a dialysis machine or take immunosuppressive medications. NKI will continue to monitor for any further developments of these projects. For more information on The Kidney Project, visit their website HERE.