A $2.25 million grant plus a $750,000 gift from the John and Marcia Goldman Foundation will help the University of California at San Francisco lead the effort to create the first implantable artificial kidney for patients with kidney failure.
It is estimated that the project will require an additional $13 million to bring the technology through the range of tests needed to enter clinical trials in humans. The funds will enable a team of bioengineers, physicians, and scientists to conduct the research and bring the proposed device to clinical trials by 2017.
The problem is severe. Roughly 2 million people worldwide live with End-Stage Renal Disease (ESRD), commonly known as chronic kidney failure, including 600,000 Americans. This figure is rising 5 percent per year with the growing rate of diabetes.
The disease is best treated via a kidney transplant, yet fewer than 18,000 of the 93,000 people on the transplant waiting list will actually receive an organ this year, and those who do are likely to need a replacement within 10 years.
As a result, roughly 400,000 Americans with ESRD survive on dialysis which comes at a high price. Medicare spends upwards of $29 billion per year or 6 percent of its total budget to treat kidney failure including $24 billion each year to pay for dialysis.
Shuvo Roy PhD Associate Professor in the UCSF School of Pharmacy is leading the Kidney Project through the UCSF Department of Bioengineering & Therapeutic Sciences. Working with the project’s Medical Director, William Fissell, MD at Vanderbilt University, Roy is coordinating researchers in nine institutions nationwide to create an implantable device that aims to mimic filtration functions of a kidney as well as the ability to maintain water and salt balances, produce Vitamin D, and regulate blood pressure and pH.
The UCSF team using silicon technology from the computer industry has designed a nano-filter for the first compartment of the device. This would offer the same level of filtration as dialysis in a box smaller than a coffee cup. A second compartment would hold live kidney cells that would perform the other biological actions of a real kidney.
The entire device would be implanted in the abdomen and powered by the body’s blood pressure without a need for external pumps or tubes. The device is also designed to be used without the immunosuppressant drugs needed in transplants.
Earlier this year, the project was selected by FDA as one of the first three pilots for a collaborative FDA review process that would address potential regulatory obstacles for the device up front before it enters the approval process.