A team of scientists, engineers and clinicians from across the United States is collaborating on a fast-track development to create an implantable kidney the size of a coffee cup to treat end-stage renal disease (ESRD), which affects more than 600,000 people in the United States.
Based at the University of California, San Francisco and at Vanderbilt University, The Kidney Project has received a $6 million boost, thanks to a new grant from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), one of the National Institutes of Health. It has also been selected by U.S. Food and Drug Administration for a new program called the Expedited Access Pathway (EAP) designed to accelerate approval of promising new technologies for treating unmet medical needs for life-threatening diseases and conditions. The EAP will facilitate collaboration between our team and the FDA to preemptively address regulatory hurdles and create an efficient roadmap and structured timeline for device approval, improving our team’s overall chance of success.
Today, people living with this devastating disease have just two treatment options: dialysis, which is costly, cumbersome and confining; and transplant, which requires a long wait, an often hard-to-find donor match and a lifetime of immunosuppressant drugs.
The mortality rate for dialysis patients is high. Only 35 percent of patients are still alive five years after starting treatment. For the fortunate few who receive kidney transplants, the outlook is much more positive. The five-year survival rate for these recipients is over 80 percent.
There is a pressing need for a treatment that gives patients the functional benefits of a live kidney in the face of an inadequate supply of donor organs.
Our team is working to meet this need with the bioartificial kidney that filters toxins from the blood, while providing many of the other functions of a healthy kidney. After a single surgery to establish a permanent blood connection, the bioartificial kidney processes blood continuously 24 hours a day, freeing patients from being tethered to dialysis machines. Just as in a natural kidney, blood pressure forces blood through the device, which means no batteries or pumps are needed. The implantable bioartificial kidney also eliminates the need for anti-rejection medications.
We expect to have a device ready for clinical trials in 2017, pending necessary funding and assuming we do not encounter any unanticipated development challenges.
Typically, at least two cycles of clinical testing are 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 our 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.
Patient support for The Kidney Project has been tremendous, as can be seen at our Facebook page: https://www.facebook.com/ArtificialKidney
To meet our deadline, we will rely increasingly on donations from individuals and private institutions as a complement to federal grant funding. The intensity of Phase 2 (our current phase) will require $3 million per year.
Thanks for this opportunity to share our important work.
Dr. Shuvo Roy is the technical director of The Kidney Project and a professor in the Schools of Pharmacy and Medicine at the University of California, San Francisco.
Dr. William H. Fissell is the medical director of The Kidney Project and a Nephrologist and professor in the Department of Medicine as part of the Division of Nephrology and Hypertension at Vanderbilt University in Nashville, Tennessee.