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The kidney is an amazing organ that works 24 hours a day, cleans the blood and treats waste. Each day, these soy-shaped, fist-sized organs on either side of the spine and under the ribs filter 150 liters of blood to produce 12 liters of urine.
Transplantation is the best treatment for kidney failure, but the demand for organs is much greater than the supply.
The US Organs Access and Transplant Network says more than 100,000 patients are on the waiting list for kidney transplants, but last year only 17,108 patients were transplanted.
Overall, the National Kidney Foundation estimates that more than 460,000 Americans have end-stage renal disease, and that 13 patients in the United States die every day while waiting for donation of kidneys. They say that federal health insurance bills for patients with kidney disease, including prescription drugs, were around $87 billion in 2012.
Nephrology specialist and medical assistant professor at the Vanderbilt University Medical Center in Nashville, Tennessee, and kidney disease specialist William H. Fissell IV and his research team hope to end this catastrophic scenario, he said:
“We are developing a bio-mixing device that simulates the kidneys to remove enough waste, salt and water so that patients no longer need dialysis.â€
The goal is to make a small enough device - about the size of the soda bottle - so that it fits into the patient.
The implanted artificial kidney contains a microchip filter and living kidney cells and will be powered by the patient's own heart.
Silicon nanotechnology plus living kidney cells
The microchip uses the same silicon nanotechnology that is used in the microelectronics industry for computers.
Professor Fissell said that the chip is cheap, accurate and has a satisfactory filtration function. Each device contains approximately 15 chips stacked one on top of the other.
Each microchip filter contains micropores, each of which will contain and serve as a scaffold for the living kidney cell membrane, which mimics the natural function of the kidney. The team is precisely designing each hole of the filter one by one, trying to make each hole look like they want.
Fortunately, Professor Fissell said, the cells grew smoothly in the petri dish in the laboratory. They can develop a kidney cell membrane that can tell which compounds can be reabsorbed back into the blood as nutrients and retained in the blood, and which are removed from the blood as waste that should be excreted through the urine.
In this way, Professor Fissell said, “We can use the 60 million years of research and development results of Mother Nature†to develop a living cell bioreactor placed at the core of the artificial kidney.
By the patient's blood flow function and no thrombosis risk
The device does not require an energy source because it uses energy from the patient's heart - the natural pressure generated in the blood vessels - to push blood through the filter.
However, this feature also presents a challenge: how to fine tune fluid dynamics so that blood can flow through the device without thrombosis.
Dr. Amanda Buck is a biomedical engineer with a strong interest in fluid mechanics and is responsible for this part of the project.
Dr. Buck used a computer model to improve the shape of the internal tubing of the device to achieve smooth blood flow. Then, with the help of 3D printing, the research team created a prototype and tested the fluency of its blood flow.
Professor Fissell said that because the bio-mixing device will not respond to the human immune response, rejection is unlikely to occur. "It's different from organ transplants, not an immune compliance, matching problem," he explained.
More than a decade of research is about to bear fruit
This kidney project began more than a decade ago. In 2003, it received the first financial grant from the National Institutes of Health (NIH), and recently the National Institutes of Health (NIH) for Professor Fissell and his research partners, Shuvo Roy, a longtime collaborator at San Francisco University, California. Provided up to 4 years, up to $6 million in funding.
In 2012, the Food and Drug Administration (FDA) gave the project a fast-track review – one that promotes and accelerates the review of drugs used to treat serious illnesses that may resolve drugs that do not meet current medical needs.
The team hopes to conduct a pilot study of silicon filters by the end of 2017. Professor Fissell said that he has a large number of patients eager to participate, and he admires these patients, as he concludes:
"My patients are definitely my heroes. They are back from ghost gates again and again. They accept a heavy burden of disease because they want to survive. They are willing to take all the risks for other patients."
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